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AGA MEDICAL; AGA Medical provides information on its latest news and research developments

Business & Finance; NMT Medical announces third-quarter 2006 revenues up 14 percent

NMT Medical; New reports from NMT Medical detailed

Hemodynamic improvement is faster after percutaneous ASD closure than after surgery

Atrial Septal Defects; New findings from Hospital, Cardiology Division describe advances in atrial septal defects

Chung Shan Medical University, Taiwan; New findings from Chung Shan Medical University, Taiwan, detailed

Patent foramen ovale: Standards for a preclinical model of prevalence, structure, and histopathologic comparability to human hearts

HEADACHE; Research from University of Bologna provide new insights into headache

Ventricular Septal Defects Prevention; New ventricular septal defects prevention findings from Children's Heart Center described

Surgery; Studies from Turkey and the United States further understanding of surgery

Percutaneous closure of ventricular septal defects in children aged <12: early and mid-term results

University Hospital Bern, Bern, Switzerland; New findings from University Hospital Bern, Bern, Switzerland, detailed

Chinese University of Hong Kong, People's Republic; Study results from Chinese University of Hong Kong, People's Republic of China, discussed

AGA MEDICAL; AGA Medical provides information on its latest news and research developments

Pharma Business Week, January 15, 2007

Report 1: AGA Medical Corp., Ample Medical Corp. and Aberdare Ventures announced the signing of an investment and joint development agreement. AGA has committed to additional investment through joint development programs for the clinical development and commercialization of Ample's PS3 System, a novel percutaneous system used to treat mitral valve regurgitation associated with congestive heart failure.

As part of the agreement, AGA will make an immediate investment in return for equity in Ample with the potential for additional investments based on successful completion of milestones. Aberdare, the majority shareholder in Ample, has also agreed to increase its investment in Ample. Terms of the agreements were not disclosed.

The PS3 System is an investigational device for the treatment of mitral valve regurgitation (MR) associated with congestive heart failure (CHF). The device is introduced through a catheter and when fully deployed the system is designed to reshape the mitral valve. An AGA occlusion device is a key component of the system.

Mitral valve regurgitation - or mitral regurgitation (also known as mitral insufficiency or incompetence) - is a condition in which the mitral valve does not close tightly, and allows blood to flow backward in the heart. The consequences of MR can accelerate CHF. As many as four million people over the age of 55 have some degree of mitral valve regurgitation associated with their CHF. An estimated 500,000 patients in the U.S. are candidates for the PS3 System with an equal number in international markets.

"We are excited about the opportunity to invest in Ample Medical and collaborate with them on the development of the PS3 System," said Franck Gougeon, president and CEO of AGA Medical. "The system not only incorporates AGA technology but addresses a large potential market where no good therapeutic solution currently exists. We are impressed with the Ample team and believe our teams complement one another and that we will be able to effectively accelerate the development of a commercial version of the system. If we are successful, this system will further expand our acknowledged leadership position in the transcatheter repair of structural heart defects." As part of the agreement Gougeon will join the board of directors of Ample.

"The investment and development partnership with AGA will greatly accelerate the development of the PS3 System," added Robert Chang, president and CEO of Ample Medical. "We look forward to collaborating with their experienced team to quickly advance our innovative technology and provide a therapeutic option to the many patients suffering from this debilitating condition."

Report 2: AGA Medical Corp. (AGA) announced that it has filed a patent infringement lawsuit against Occlutech GmbH, headquartered in Jena, Germany, and DRABO Medizintechnik, located in Cologne, Germany.

AGA is the owner of a European patent (EP 0 808 138) validated in Germany (DE 695 34 505) for intravascular occlusion devices and the method of forming or manufacturing these medical devices. The patent issued in October 2005. The action, filed in Dusseldorf, requests damages against Occlutech, DRABO, their CEOs and further requests a permanent injunction prohibiting them from manufacturing and marketing infringing "Figulla Occluder."

"Using all legal methods possible, AGA Medical will vigorously defend against any infringement of our intellectual property anywhere in the world. AGA has made a substantial investment in the development and marketing of our occlusion devices. Our devices lead the market in sales and innovation; we will not tolerate even the most minor violation of our patents," said Franck Gougeon, president and CEO of AGA.

Report 3: AGA Medical Corp. announced that it has reached an agreement with BVM, Ltd., headquartered in Hinckley, Leicestershire in the U.K. to terminate the distribution agreement.

Terms include an unspecified upfront payment followed by three milestone payments tied to sales of AGA products in the former sales territory during the next 3 years. The agreement also provides for support during a transition period while AGA expands the operations of its wholly owned subsidiary Amplatzer Medical U.K., Ltd., AGA has also agreed to hire key members of the BVM sales team that serviced hospital customers in the U.K.

In 1997, BVM was named the first distributor for AGA products worldwide. The announcement of the new agreement followed discussions between the two companies over several months regarding a change in the agreement as well as extensive planning for the transition. In addition to providing direct distribution of AGA Medical products in the U.K., Amplatzer Medical, Ltd., will be used as a platform to expand European operations to better service AGA customers in the region. AGA Medical currently sells directly in Germany, Austria, Switzerland, Sweden, Norway, Finland, and Denmark.

"I would like to first thank the entire BVM team for partnering with AGA to build a very successful business in the U.K., said Franck Gougeon, president and CEO of AGA Medical. "This agreement will enable AGA Medical to get closer to our U.K. customers at an important time for the company. We plan to increase our investment in this business to accelerate our growth, prepare for the launch of future products, and better serve our European customers. Our strategy is to continue to work with our distributor partners in key countries while building our own organizational capabilities in select markets and taking full advantage of the associated improved economics."

Jay Tailor, president and CEO of BVM, Ltd., also commented, "I am personally very proud of the work we have done in successfully introducing AGA Medical products in the U.K. and making them the standard of care for the transcatheter repair of structural heart defects. As a result of this partnership, we have built a wonderful team at BVM that will now focus its considerable talents on distributing our other product lines to hospitals. We are committed to working with AGA to provide a seamless transition for our customers."

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USE OF MEDICAL DEVICES TO HELP PETS IS INCREASING; [ALL Edition]

The Augusta Chronicle. Augusta, Ga.: Jan 7, 2007. pg. D.05

Moore, Janet

Dick Van Keuren gently kissed Kelly's head, a downy patch of coal- gray fur.

"You're OK, aren't you?" he murmured, more to himself than the 12-year-old miniature schnauzer, who slurped his face in three wet strokes.

As he negotiated the cavernous hallways at the University of Minnesota's Veterinary Medical Center in St. Paul recently, the River Falls, Wis., resident seemed deeply worried. Despite the assurances of the university's veterinary team, Mr. Van Keuren faced a decision dreaded by many pet owners: Prolong the life of a pet with an involved - and expensive - medical procedure, or let the beloved animal decline.

"I really thought long and hard about this," Mr. Van Keuren said.

The next day, Kelly was anesthetized and covered in blue surgical draping in an operating room. In a two-hour procedure, a pacemaker intended for humans was implanted behind her shoulder blade, and an insulated wire burrowed beneath the skin, through the jugular vein to her right ventricle. Ultimately, the device would send electrical pulses to stimulate Kelly's weakened heart when needed.

Each year, the university implants 10 to 15 dogs with pacemakers donated by Medtronic Inc. of Fridley, Minn. The devices are strictly for therapeutic use and not for research purposes - and the procedure is at the behest of pet owners willing to pay up to $2,500. That figure doesn't include about $800 in tests before the implant.

Because dogs are physiologically similar to humans in many ways, it makes sense that human devices would be used to treat their various conditions and diseases - such as faulty hearts and bum hips. The market for such devices is fledgling and fragmented, and the university does not implant used pacemakers, such as those taken from cadavers.

"It's amazing to me that device companies like Medtronic work with us, because financially, there's not much in it for them," said Anthony Tobias, a veterinary cardiologist at the university. "I think they find it rewarding."

Medtronic says it donates unused pacemakers to the university at the end of their shelf life - although they're still functional.

The company also provides technical support to program the device. Timothy Vaughn, a principal technical consultant for Medtronic who was involved in Kelly's treatment, has helped in many canine procedures over the years. A dog owner, Mr. Vaughn calls it a labor of love.

Dr. Tobias and his team are especially excited about new methods of veterinary device treatment that are minimally invasive and need no surgery. Such procedures are intended to be easier not only on the pet but also on the often-distraught pet owner. He has teamed with AGA Medical Corp. to develop what is believed to be one of the first minimally invasive cardiology devices made specifically for dogs.

Called the Amplatz Canine Duct Occluder, the thumbnail-sized mesh device corrects a congenital heart defect called patent ductus arteriosus occlusion and serves as an alternative to opening the dog's chest in major surgery.

Dr. Tobias and Dr. Kurt Amplatz, the founder of AGA Medical and a medical-technology pioneer, developed several versions of the device before perfecting it. "We thought that perhaps we could make a viable product for the animal," said Franck Gougeon, AGA's president and CEO.

Mr. Gougeon has no illusion of a burgeoning new marketplace for veterinary devices. "It's not going to be a very lucrative business for us, but it's a nice thing to do," he said.

Kelly and Mr. Van Keuren were reunited at the university clinic the day after surgery. Mr. Van Keuren was advised to keep the dog quiet for two weeks for fear of disturbing her pacemaker leads, and Kelly was prescribed antibiotics to prevent infection.

Kelly pawed happily at Mr. Van Keuren's blue sweatshirt

"I think I did the right thing," he said.

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Business & Finance; NMT Medical announces third-quarter 2006 revenues up 14 percent

Medical Devices & Surgical Technology Week. Atlanta: Dec 17, 2006. pg. 50

2006 DEC 17 - (NewsRx.com) -- NMT Medical, Inc. (NMTI) announced financial results for the third quarter with total revenues up 14% to approximately $6.9 million compared with approximately $6.0 million for the quarter ended September 30, 2005.

Total revenues for the third quarter of 2006 include approximately $1.6 million of net royalties, compared to approximately $1.1 million for the same period in 2005. Worldwide CardioSEAL and STARFlex cardiac septal repair implant sales for the third quarter of 2006 increased to approximately $5.3 million, from approximately $4.9 million for the third quarter of 2005.

Implant sales in North America for the third quarter of 2006 were approximately $4.7 million compared with approximately $4.2 million in the third quarter of 2005. European implant sales in the third quarter of 2006 were approximately $657,000 compared with approximately $715,000 in the same period in 2005.

For the third quarter of 2006, NMT Medical reported a net loss of approximately $1.4 million, or $0.11 per share. This compares with a net loss of approximately $2.1 million, or $0.17 per share, for the comparable period in 2005. For the third quarter of 2006, NMT recorded an income tax provision of $50,000 based on the company's current forecast of full-year net income. The company did not provide a tax provision during the third quarter of 2005.

"NMT performed well in the third quarter of 2006," stated president and chief executive officer John E. Ahern.

"During the third quarter we received approval from the U.S. Food and Drug Administration (FDA) to amend the endpoint of the MIST II PFO/migraine trial in the U.S. and also to incorporate our latest septal repair technology, BioSTAR, into the trial," said Ahern. "We supported the requested changes by providing the FDA with full data and clinical evidence from our recently completed clinical trials -- MIST (Migraine Intervention with STARFlex Technology) and BEST (BioSTAR Evaluation STudy). We believe that patients receiving treatment in the MIST II study will benefit from the advantages of our BioSTAR implant. In addition, the MIST II clinical research team and the patients they enroll will participate in the only clinical trial designed to reflect clinical evidence from a predicate PFO/ migraine study, MIST. We believe these modifications are being well received by both the medical community and patients alike, and we currently anticipate a steady enrollment process."

Total revenues for the nine months increased 19% to approximately $20.9 million from approximately $17.7 million for the comparable period in 2005.

NMT Medical is an advanced medical technology company that designs, develops, manufactures and markets proprietary implant technologies that allow interventional cardiologists to treat structural heart disease through minimally invasive, catheter-based procedures.

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NMT Medical; New reports from NMT Medical detailed

Life Science Weekly. Atlanta: Jan 9, 2007. pg. 1057

2007 JAN 9 - (NewsRx.com) -- New reports from NMT Medical detailed.

This trend article is an immediate alert from NewsRx to identify the most recent news developments at NMT Medical.

Report 1: NMT Medical, Inc. (NMTI) has filed a shelf registration statement on Form S-3 with the Securities and Exchange Commission (SEC). If and when the shelf registration statement is declared effective, it will permit the company from time to time, to offer and sell up to $65 million of equity or debt securities.

The offering of securities covered by the shelf registration statement is designed to provide the company with greater flexibility to take advantage of financing opportunities, subject to market conditions and the capital requirements of the company.

As of the date of this release, the company has no specific plans to offer the securities covered by the registration statement and is not required to offer the securities in the future.

The terms of any offering under the registration statement will be established at the time of the offering and will be described in a prospectus supplement filed with the SEC at the time of the offering. Unless otherwise indicated in a prospectus supplement, the proceeds from the sale of any securities will be used for general corporate purposes including, but not limited to, sales and marketing expansion, working capital, capital expenditures, continuing research and development, acquisitions and investments.

Report 2: NMT Medical, Inc. (NMTI) announced total revenues for the first quarter ended March 31, 2006 increased 32% to approximately $6.9 million compared with approximately $5.3 million for the quarter ended March 31, 2005.

Total revenues for the first quarter of 2006 included approximately $1.2 million of net royalties, compared to approximately $1.1 million for the same period in 2005. Worldwide CardioSeal and StarFlex cardiac septal repair implant sales for the first quarter of 2006 rose approximately 38% year-over-year to approximately $5.7 million compared with approximately $4.1 million for the first quarter of 2005.

The growth in implant sales was attributable to a $1.8 million increase in North American sales to approximately $5.1 million from approximately $3.3 million in the first quarter of 2005. European implant sales in the first quarter of 2006 were approximately $600,000 compared with approximately $800,000 in the same period in 2005.

Report 3: NMT Medical, Inc. (NMTI) announced results of its Migraine Intervention with StarFlex Technoloy (MIST) study at the American College of Cardiology's 55th Annual Scientific, Late- Breaking Clinical Trials Sessions that show positive results from patent foramen ovale (PFO) closure on migraine headaches .

Doctors Peter Wilmshurst and Andrew Dowson, coprimary investigators of MIST, jointly presented the results. Wilmshurst is consultant cardiologist at Royal Shrewsbury Hospital, Shrewsbury. Dowson is director of the King's Headache Service, Kings College Hospital, London.

MIST, which was conducted in the United Kingdom, is the first prospective, randomized, double-blinded study to evaluate the effect of PFO closure on migraine headaches using NMT's proprietary PFO closure technology, StarFlex. A PFO is a common heart defect that is a risk factor for migraine headaches in some patients. The PFO allows venous blood, unfiltered and unmanaged by the lungs, to enter the arterial blood circulation. The unfiltered venous blood may contain elements that can trigger migraines in some patients.

The study, which screened 432 migraine with aura patients for a PFO, enrolled 147 patients into the study. A significant finding in the MIST study is that over 60% of those screened had a right to left shunt. A shunt is a heart defect, which allows blood to cross from the right to left chambers of the heart, bypassing the lungs. Of those patients, almost 40% had a moderate or large PFO, six times greater than the general population.

Wilmshurst said, "With no prior randomized, double blind study to draw from, MIST was designed and primary endpoints were selected based upon a review and analysis of several previously reported device observational and migraine drug studies."

He continued, "Consistent with what was reported in the observational studies, we selected a challenging primary endpoint of 40% elimination in migraine headache at 6 months in the treatment group. Preliminary analysis of MIST data did not satisfy that endpoint, however, we are seeing a significant treatment effect and promising trend to support PFO closure with StarFlex as a treatment option for certain types of migraine."

As reported, MIST results indicated an approximate 37% reduction in migraine burden (number of headaches multiplied by the length, in hours of headache) in those patients who received a STARFlex implant and a 17% reduction in those who received the sham procedure and no implant. This represents a statistically significant treatment effect. It also was reported that this variance appears to increase over time.

Andrew Dowson added, "For the first time we can see trends in a prospective study to suggest that PFO closure may be an effective way to treat certain types of migraine. A reduction in headache burden for a patient with severe migraine may allow that individual to gain more control and lead a more fulfilling and productive life. The key now will be establishing the criteria that will help to determine which patients should be referred to the interventional cardiologist for further treatment."

Wilmshurst added, "This study significantly increases our understanding of those patients who might benefit from cardiac intervention to treat these debilitating headaches. The results, arising from an unprecedented collaboration between cardiac and headache doctors, are a precursor to what we believe could be an exciting development in migraine treatment."

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Hemodynamic improvement is faster after percutaneous ASD closure than after surgery.

Catheter Cardiovasc Interv. 2006 Dec 28; [Epub ahead of print]

Eerola A, Pihkala JI, Boldt T, Mattila IP, Poutanen T, Jokinen E.

Department of Pediatrics, University Hospital of Kuopio, Kuopio, Finland.

Objectives: Hemodynamic effects of surgical and percutaneous closure of atrial septal defect (ASD) were evaluated. Background: ASD causes volume overload of right ventricle (RV) and is associated with distortion and dysfunction of left ventricle (LV). The amount and timing of hemodynamic changes after ASD closure are not well known. Methods: The study group consisted of 7 children treated surgically and 17 treated in the catheterization laboratory. In the control group, there were 51 healthy children. RV size and LV end-diastolic and systolic dimensions, volumes, and function were examined by two- and three- dimensional echocardiography and serum concentrations of natriuretic peptides measured prior to ASD closure, and 1, 6, and 12 months thereafter. Results: In all children with ASD, during the 1-year follow-up, the z score of RV end-diastolic diameter decreased from a median 5.00 SD to 2.25 SD (P < 0.001). Dilatation of RV did not resolve entirely during 1-year follow-up in either treatment group. End-diastolic LV diameter increased from -1.50 to -0.50 SD (P < 0.001). LV size increased slower in the surgical subgroup but reached control levels in both groups. Concentrations of natriuretic peptides increased during the first month after ASD closure and normalized thereafter in patients treated percutaneously but remained higher than in controls in patients treated surgically. Conclusions: During 1-year follow-up after ASD closure, RV size decreases but does not normalize in all patients. The size of the LV normalizes after ASD closure but the increase in LV size is slower in patients treated surgically. Serum levels of ANPN and proBNP are elevated prior to ASD closure but decrease thereafter to control levels in patients treated with the percutaneous technique but not in those treated surgically. (c) 2006 Wiley-Liss, Inc.

PreMedline Identifier: 17195197

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Atrial Septal Defects; New findings from Hospital, Cardiology Division describe advances in atrial septal defects

Cardiovascular Week. Atlanta: Jan 15, 2007. pg. 55

Raghu, A

2007 JAN 15 - (NewsRx.com) -- Researchers detail in "Embolic stroke due to a left atrial thrombus two years after placement of an atrial septal defect closure device," new data in atrial septal defects. According to recent research from the United States, "A 29- year-old woman who had undergone closure of a secundum-type atrial septal defect using the Amplatzer device 2 years previously developed acute and progressive altered mentation."

"Initial clinical and imaging data confirmed the diagnosis of multiple cerebral, cerebellar and brain stem emboli, and infarcts. She was treated urgently with an intra-arterial thrombolytic agent with only minimal improvement. Transesophageal echocardiography revealed a large thrombus attached to the left atrial disc of the atrial septal defect occluder, which was the source of the emboli," wrote A. Raghu and colleagues, Hospital, Cardiology Division.

The researchers concluded: "This is the first reported case, to our knowledge, of disseminated cerebral emboli and infarctions as a late complication of transcatheter closure of a secundum-type atrial septal defect."

Raghu and colleagues published their study in American Journal of Cardiology (Embolic stroke due to a left atrial thrombus two years after placement of an atrial septal defect closure device. American Journal of Cardiology, 2006;98(9):1294-6).

For additional information, contact A. Raghu, Presbyterian Hospital of Dallas, Presbyterian Hospital of Dallas, Cardiology Division, Dallas, Texas U.S.

Publisher contact information for the American Journal of Cardiology is: Excerpta Medica Inc., 650 Avenue of the Americas, New York, NY 10011, USA.

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Chung Shan Medical University, Taiwan; New findings from Chung Shan Medical University, Taiwan, detailed

Pharma Business Week. Atlanta: Dec 25, 2006. pg. 657

Chien-Kuo

Real time 3-dimensional transthoracic echocardiography (RT3D-TTE) is a feasible, safe, and effective alternative for guiding Amplatzer septal occluder (ASO) deployment.

According to recent research published in the journal Echocardiography, "Transcatheter ASO device closure of atrial septal defects (ASDs) has traditionally been guided by 2-dimensional transesophageal echocardiography (2D-TEE) and intracardiac echocardiography (ICE) modalities. RT3D-TTE provides rotating images to define ASD and adjacent structures with potential as an alternative to 2D-TEE or ICE for guiding the device closure of ASD."

F.L. Chen and colleagues, Chung Shan Medical University, wrote, "Our aim was to assess the feasibility and effectiveness of RT3D- TTE in parasternal four-chamber views to guide ASO device closure of ASD. From July 2004 to August 2005, 59 patients underwent transcatheter ASO device closure of ASD. The first 30 patients underwent 2D-TEE guidance under general anesthesia and the remaining 29 patients underwent RT3D-TTE guidance with local anesthesia. All interventions were successfully completed without complications."

They continued, "The clinical characteristics and transcatheter closure variables of RT3D-TTE and 2D-TEE were compared. Echocardiographic visualization of ASD and ASO deployment was found to be adequate when using either method. Catheterization laboratory time (39.1+-5.4 vs 78.8+-14.1 minutes, p<.001) and interventional procedure length (7.6+-4.2 vs 15.3+-2.9 minutes, p<.001) were shortened by using RT3D-TTE as compared with 2DE-TEE.

"There was no difference in the rate of closure following either method, assessed after a 6-month follow-up. The maximal diameter measured by RT3D-TTE and 2D-TEE was correlated well with a balloon- stretched ASD size (y=0.985x + 0.628, r=0.924 vs y=0.93x + 2.08, r=0.885, respectively)."

The researchers concluded, "RT3D-TTE may be a feasible, safe, and effective alternative to the standard practice of using 2D-TEE to guide ASO deployment."

Chen and colleagues published their study in Echocardiography (Real time 3-dimensional transthoracic echocardiography for guiding Amplatzer septal occluder device deployment in patients with atrial septal defect. Echocardiography, 2006;23(9):763-770).

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Patent foramen ovale: Standards for a preclinical model of prevalence, structure, and histopathologic comparability to human hearts.

Catheter Cardiovasc Interv. 2006 Dec 15; [Epub ahead of print]

Hara H, Virmani R, Ladich E, Mackey-Bojack S, Titus JL, Karnicki K, Stewart M, Pelzel JM, Schwartz RS.

Minneapolis Heart Institute and Foundation, Minneapolis, Minnesota.

Background: This study evaluated and standardized a Patent Foramen Ovale (PFO) preclinical model in gross anatomic and histopathologic features. Methods: We examined 150 necropsy-derived domestic porcine hearts, age 4-6 months for PFO prevalence, appearance, and size. Histopathologic preparations were standardized and processed identically to 24 post-mortem human hearts aged 16-62 years. A measurement scheme was developed for PFO atrial openings, tunnel length, and histopathologic features to compare porcine and patient hearts. Results: PFO was found in 32 of the 150 porcine hearts (prevalence 21.3%). Twenty-five porcine PFO underwent standard characterization by tunnel length, and right, and left atrial orifice diameters. Logarithmic regression analysis between porcine PFO tunnel length and left atrial orifice area demonstrated a significant positive relationship (P = 0.0162, R(2) = 0.227). The porcine PFO tunnel length was significantly longer than in humans (12.0 +/- 4.0 mm vs. 7.1 +/- 3.1 mm respectively, P < 0.0001). Histopathologic comparison was made using serial sections perpendicular to the atrial septum and the tunnel long axis. Human and porcine PFO lesions demonstrated strong similarities in tissue cells, connective tissue, and matrix composition. Conclusions: PFO assessment was standardized in both macroscopically and histopathologically, with quantitative and qualitative comparisons feasible using a porcine preclinical model. PFO prevalence in domestic swine is identical to humans, and microscopic structures very similar to humans. The domestic swine PFO model appears useful to evaluate new interventional closure technologies due to comparability in microscopic features. Tunnel length should be carefully evaluated due to differences across pigs and patients. (c) 2006 Wiley-Liss, Inc.

PreMedline Identifier: 17173313

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HEADACHE; Research from University of Bologna provide new insights into headache

Medical Device Law Weekly, December 24, 2006

Data detailed in "Transcatheter patent foramen ovale closure using the premere PFO occlusion system" have been presented. According to recent research from Italy, "To evaluate the safety and efficacy profile of the new Premere patent foramen ovale (PFO) occlusion system. Several different devices have been used so far for transcatheter PFO closure but no data has been published so far on the efficacy and safety of the Premere PFO occlusion system. Since September 2005, 15 patients (seven males, eight females; mean age 51.2 ±10.8 years) at our institution underwent transcatheter PFO closure because of cryptogenic stroke, using the Premere PFO occlusion system."

"The procedure was performed under fluoroscopic and transesophageal echocardiographic (TEE) guidance in all patients. Seven patients (47%) had an associated atrial septal aneurysm and two patients had had >1 stroke. Five patients (33%) had an associated thrombophilia, whereas three patients (20%) had a diagnosis of migraine headache with aura, by the referring neurologist. Residual shunt was assessed immediately after and 1 month (only in 11 patients) after the procedure by both transcranial Doppler and TEE. Premere PFO devices could be implanted in all patients (20 mm size in seven patients, 25 mm size in eight). Fluoroscopy time was 7.3 ±1.9 and procedural time was 11 ±3 min (range 7-17 min), reflecting our initial learning curve with this device. No complication occurred during the procedure or at follow-up. A residual shunt was noted immediately after the procedure in eight patients (53%) and at 1 month in 4/11 patients (36%). Residual shunt was mild in all patients. After a median follow-up of 4.2 months (0.2-5.8 months), no patient had a recurrent stroke. All patients with migraine headache with aura had resolution of symptoms," wrote A. Donti and colleagues, University of Bologna.

The researchers concluded: "Our preliminary experience with the Premere PFO occlusion system shows that this device is safe and effective."

Donti and colleagues published their study in Catheterization and Cardiovascular Interventions (Transcatheter patent foramen ovale closure using the premere PFO occlusion system. Catheterization and Cardiovascular Interventions, 2006;68(5):736-40).

For additional information, contact A. Donti, University of Bologna, Pediatric Cardiology and Adult Congenital Unit, Institute of Cardiology, Italy.

Publisher contact information for the journal Catheterization and Cardiovascular Interventions is: Wiley-Liss, Division John Wiley & Sons Inc., 111 River St., Hoboken, NJ 07030, USA.

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Ventricular Septal Defects Prevention; New ventricular septal defects prevention findings from Children's Heart Center described

Cardiovascular Week. Atlanta: Jan 15, 2007. pg. 212

Handke, R

2007 JAN 15 - (NewsRx.com) -- A report, "Transcatheter closure of perimembranous ventricular septal defects using umbrella devices," is newly published data in Catheterization and Cardiovascular Interventions. "There is only limited experience of interventional closure of perimembranous ventricular septal defects (pmVSDs), particularly on the long-term follow-up. This is a report on our long-term results after transcatheter closure of pmVSDs using the Cardioseal, Starflex, or Rashkind devices. Between 1993 and 2005, we performed interventional occlusions of pmVSDs in 18 patients," investigators in Germany report.

"The size of the defect ranged between 4 and 8.5 mm, Q(p)/Q(s) was calculated between 1.3 and 2.2. Except for two, the patients had no other structural heart defect. In the early days, we used the Rashkind PDA occluder (17 mm) in seven, followed by the Cardioseal device (17 mm) in nine, and the 23 mm Starflex device in two patients. Interventional closure of the defects was performed successfully in all patients without any complication during the procedure. Fluoroscopy times were 11.8-53.7 min (median 28.65 min). We achieved a complete closure in 13 patients, three patients with recently implanted devices still show minimal shunting. In two patients the occluder had to be removed surgically because of embolization into the pulmonary artery and significant residual shunting resulting in severe hemolysis in the second patient. In long-(mean 10.7 years) and short-term (mean 0.85 years) follow-up we have not observed any hemolysis, arrhythmias, device dislocations, or device-related aortic or tricuspid regurgitation. Transcatheter closure of small pmVSDs using non-selfcentering devices can be performed successfully. Long-term follow-up investigations show encouraging results," wrote R. Handke and colleagues, Children's Heart Center.

The researchers concluded: "Complications like device- embolization and significant residual shunting occur in the presence of large defects and/or concomitant malformations."

Handke and colleagues published their study in Catheterization and Cardiovascular Interventions (Transcatheter closure of perimembranous ventricular septal defects using umbrella devices. Catheterization and Cardiovascular Interventions, 2006;68(6):936- 41).

For additional information, contact R. Handke, The Children's Heart Center St. Augustin, Dept. of Paediatric Cardiology, St. Augustin, Germany.

The publisher of the journal Catheterization and Cardiovascular Interventions can be contacted at: Wiley-Liss, Division John Wiley & Sons Inc., 111 River St., Hoboken, NJ 07030, USA.

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Surgery; Studies from Turkey and the United States further understanding of surgery

Gastroenterology Week. Atlanta: Jan 15, 2007. pg. 450

Transcatheter closure of a perimembranous ventricular septal defect (PmVSD) using the new Amplatzer Membranous VSD Occluder is technically feasible and seems safe enough in children over 8 kg in weight to warrant continuation of clinical trials.

According to recent research from the United States, "This phase I study attempted to report the initial safety and efficacy results of transcatheter closure of perimembranous ventricular septal defects (PmVSDs) using the new Amplatzer Membranous VSD Occluder (AGA Medical Corp., Golden Valley, Minnesota) in the U.S. The most common congenital heart disease is PmVSD. Surgical repair is widely accepted, but still carries a small but definite risk of morbidity and mortality."

Y.C. Fu and colleagues at University of Chicago explained, "Between October 2003 and August 2004, a total of 35 patients with PmVSD underwent an attempt of transcatheter closure under transesophageal and/or intracardiac echocardiographic guidance. The median age was 7.7 years (range, 1.2 to 54.4 years) and median weight was 25 kg (range, 8.3 to 110 kg). The median Qp/Qs ratio was 1.8 (range, 1 to 4), and the median VSD size as assessed by echocardiography was 7 mm (range, 4 to 15 mm)."

"The attempt to place a device was successful in 32 patients (91%)," the researchers reported. "The median device size used was 10 mm (range, 6 to 16 mm). The complete closure rates by echocardiography at 10 min (transesophageal/intracardiac), 24 h, 1 month, and 6 months (transthoracic) were 47% (15/32), 63% (20/32), 78% (25/32), and 96% (27/28), respectively. The median fluoroscopy time was 36 min (range, 14 to 191 min), and the median total procedure time was 121 min (range, 67 to 276 min)."

"Three patients (8.6%) had serious adverse events of complete heart block, peri-hepatic bleeding, and rupture of tricuspid valve chordae tendineae. No other patient encountered serious adverse events during the follow-up," the authors noted.

They concluded, "Transcatheter closure of a PmVSD is technically feasible and seems safe enough in children over 8 kg in weight to warrant continuation of clinical trials to assess the long-term safety and efficacy."

Fu and colleagues published their study in the Journal of the American College of Cardiology (Transcatheter closure of perimembranous ventricular septal defects using the new Amplatzer Membranous VSD Occluder - Results of the US phase I trial. J Am Coll Cardiol, 2006;47(2):319-325).

For additional information, contact Z.M. Hijazi, University of Chicago, Comer Children's Hospital, Section of Pediatric Cardiology, Dept. of Pediatrics, Pritzker School of Medicine, 5841 S Maryland Avenue, MC4051, Chicago, IL 60637, USA.

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Percutaneous closure of ventricular septal defects in children aged <12: early and mid-term results

European Heart Journal. London: Dec 2006. Vol. 27, Iss. 23; pg. 2889

Aims The aim of the article is to study the safety, efficacy, and follow-up of percutaneous closure of muscular ventricular septal defect (mVSD) and perimembranous ventricular septal defect (pmVSD) in children.

Methods and results Between January 2000 and June 2005, among 140 patients who underwent percutaneous closure of an mVSD or a pmVSD, 88 were aged lt;12. Two different Amplatzer devices were used: the mVSD occluder and the pmVSD occluder. Mean age and weight at procedure were 4.5±3.3 years and 18.7±11.2 kg, respectively. Percutaneous closure was successfully achieved in 83 subjects (94%). No deaths occurred. Thirteen patients (14.7%) had early complications: device embolization (n=4), vascular complications (n=3), and rhythm abnormalities (n=6). These were transient complications in all but one case [1.1% complete atrioventricular block (cAVB) needing pacemaker implantation]. During a median follow-up of 24 months, three subjects treated for a pmVSD needed pacemaker implantation due to the occurrence of cAVB. Multivariable analysis using Cox's proportional hazard regression showed that age was the only risk factor associated with the occurrence of cAVB (P=0.028; relative risk: 0.25).

Conclusion Percutaneous closure of mVSD and pmVSD in children can be performed safely and successfully. The occurrence of cAVB is a major concern in young children with pmVSD.

Proquest Identifier: 1171081061
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University Hospital Bern, Bern, Switzerland; New findings from University Hospital Bern, Bern, Switzerland, detailed

Pharma Business Week. Atlanta: Jan 1, 2007. pg. 948

Meier, B

Erosion-induced atrial septal defects are a new medical entity.

According to a recent report from Switzerland, "Iatrogenic atrial septal defects are described in 2 patients. They occurred after implantation of Amplatzer occluders to close a patent foramen ovale."

"While device erosions to the extra-atrial space have been described, erosion induced atrial septal defects are a new medical entity," explained B. Meier at University Hospital Bern. "They may be fairly common in the situation of an atrial septal aneurysm whipping the rim of the device incessantly. They are clinically silent and benign and require echocardiography for detection."

"A second device solved the problem in the cases described," the author noted.

Meier published the report in Catheterization and Cardiovascular Interventions (Iatrogenic atrial septal defect, erosion of the septum primum after device closure of a patent foramen ovale as a new medical entity. Catheter Cardiovasc Interv, 2006;68(1):165- 168).

For additional information, contact B. Meier, University Hospital Bern, Swiss Cardiovascular Center of Bern, CH-3010 Bern, Switzerland.

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Chinese University of Hong Kong, People's Republic; Study results from Chinese University of Hong Kong, People's Republic of China, discussed

Science Letter. Atlanta: Jan 9, 2007. pg. 1065

Wang, T

New research, "Atrial strain rate echocardiography can predict success or failure of cardioversion for atrial fibrillation: a combined transthoracic tissue Doppler and transoesophageal imaging study," is the subject of a report. According to recent research published in the International Journal of Cardiology, "The purpose of this study was to assess the feasibility of measuring left atrial dysfunction with tissue Doppler imaging derived strain rate and to explore its role in predicting the maintenance of sinus rhythm after cardioversion for atrial fibrillation. Strain rate (SR) and tissue Doppler imaging (TDI) were performed with offline analysis of the basal left atrial wall (LA). SR detected a systolic (Ssr) and early diastolic (Esr) deformation induced by ventricular motion."

"LA dimensions and volume were measured. Left atrial appendage emptying (LAA_EV) and filling (LAA_FV) velocities were also obtained by transesophageal echocardiography. 27 healthy age-matched controls and 42 patients with AF before cardioversion were studied. Patients were grouped into (1): those who remained in sinus rhythm (group S, n=12) and (2) those who either failed cardioversion or reverted to AF within 4 weeks (group F, n=30). LA dimensions were significantly larger and atrial Esr was significantly lower in group F than group S (all p<0.01). LAA_EV and LAA_FV were not different between groups S and F. Multivariate regression analysis showed that a lower Esr and larger transverse LA diameter (LADtr) were independent predictors of failure of cardioversion (HR, 95% CI: 0.36, 0.14-0.88 and 2.85, 1.33-6.10, respectively). Esr combined with LADtr improved the sensitivity and specificity for predicting successful cardioversion," wrote T. Wang and colleagues, Chinese University of Hong Kong.

The researchers concluded: "SR can be measured in the basal LA wall in atrial fibrillation and the magnitude of the early diastolic SR could predict the success of cardioversion and the likelihood of maintenance of sinus rhythm."

Wang and colleagues published their study in International Journal of Cardiology (Atrial strain rate echocardiography can predict success or failure of cardioversion for atrial fibrillation: a combined transthoracic tissue Doppler and transoesophageal imaging study. International Journal of Cardiology, 2007;114(2):202-9).

For additional information, contact T. Wang, Prince of Wales Hospital, The Chinese University of Hong Kong, Dept. of Medicine and Therapeutics, The Chinese University of Hong Kong, Hong Kong, SAR, China.

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Epicardial isolation of the left atrial appendage

Carnegie Mellon University, 2006, 154 pages; AAT 3211843

Gartner, Mark, Ph.D.

Atrial fibrillation (AF) is the most common cardiac dysrhythmia in adults currently affecting over two million Americans with an additional 160,000 new cases diagnosed each year. The greatest risk associated with AF is stroke. The American Heart Association estimates that 25 percent of all strokes may be related to AF with associated costs exceeding $43 billion per year. AF-related stroke also tends to exhibit greater morbidity and mortality due to larger thrombus sizes associated with cardioembolism.

Currently, the most widely used therapy for stroke prevention in patients with AF is oral anticoagulation with warfarin to increase blood-clotting times. However it has been reported that, while warfarin can significantly reduce risk, it remains both underutilized (only 34.7 percent of eligible patients in one study) and ineffectively utilized (over 50 percent of patients with clotting times out of range in another study).

Since over 90 percent of AF-related thrombus has been shown to originate in the left atrial appendage (LAA), there has been recent resurgence in efforts to eliminate this appendage using novel percutaneous techniques since currently appendage obliteration is only performed when part of a surgical cardiac procedure. However, the percutaneous implants used to achieve LAA obliteration require advanced deployment techniques and, since in direct contact with blood, present several blood-biomaterial complications.

This thesis describes research on epicardial isolation of the LAA using a custom designed delivery tool and implantable snare. In vitro and in situ studies were conducted to characterize the porcine right atrial appendage---a surrogate for the human LAA. This information, in addition to published human clinical data, was used as the basis for design of a delivery tool and implantable snare. Three distinct prototypes iterations were fabricated and tested in vitro, in situ , and in vivo based on a porcine animal model. Data from in vitro studies provided information on the overall functionality and usability of that particular design iteration. Three acute in vivo tests were conducted to further adjudicate the performance of the each prototype with respect to the established performance specifications. The final design iteration was tested in two chronic in vivo experiments, lasting 23 and 43 days respectively. The results from these chronic experiments demonstrated that the implantable snares were easily deployed and showed no degree of migration or failure over the implant periods. Furthermore, both animals exhibited excellent health throughout post-operative recovery periods with favorable wound healing.

Proquest Identifier: 1140193191
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