Final Results are now in... regarding Treatment of Critical Limb Ischemia Using Ultrasound-enhanced Thrombolysis (PARES Trial). The PARES Trail tested a new and novel thrombolysis treatment, the Lysus Peripheral Catheter System developed by EKOS Corporation (Bothell, Washington) for acute thrombotic or embolic lower limb arterial occlusion. Twenty five (25) patients were recruited with the Lysus system demonstrating a 100% technical success rate. The system was also found to be safe and effective. The principal investigators for this trial are Christian Wissgott, MD, Functional Senior Physician, and Hermann J. Steinkamp, MD, Professor, Chief Doctor & Head of the Department, Department of Radiology, DRK Kliniken Mark Brandenburg Hospital, Berlin, Germany.

Dr. Wissgott shared conclusions on the PARES study results by stating, "This study demonstrates that local lysis of acute arterial occlusions using the Lysus Peripheral Catheter System is safe and effective. Blood flow is restored quickly."

For a MIB MarketTracks snapshot of this PARES Trial results click the trial name.

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On September 20, 2007, LeMaitre Vascular (Burlington, Massachusetts) announced the successful acquisition of Vascular Architects (San Jose, California). This merger allows LeMaitre access to the privately-held medical device company's Remote Endarterectomy ("RE") technology. ARE technology is used in hybrid open/endovascular procedures for the minimally invasive removal of plaque, typically in the superficial femoral artery. The reported purchase price of $2.8 million all-cash, represents a 1.6 multiple of the acquired company's last-twelve-months' net revenues of $1.8 million.

LeMaitre Vascular develops peripheral vascular devices and implants for the treatment of peripheral vascular disease.

3) Gore Helex Septal Occluder Receives FDA Approval

“In treating such a delicate area of the heart, particularly in small children, interventional cardiologists need to be confident that treatment will be effective for the long term,” said Dr. Alexander Javois, The Heart Institute for Children, Advocate Hope Children’s Hospital, Oak Lawn, Illinois. “Percutaneous ASD closure is successful in the very young patient using the GORE HELEX Septal Occluder."

On October 3, 2007, W. L. Gore & Associates (Flagstaff, Arizona) announced that they had received FDA approval for the GORE HELEX Septal Occluder. This device is composed of ePTFE material supported by a nitinol wire frame. Designed to occlude atrial septal defects this device enters the market allowing care providers and patients yet another option for Cardiac Structural Defect therapies.

The GORE HELEX is a first-of-its-kind permanently implanted prosthesis for ASD closure to gain FDA approval.

Keep tabs on your competition - get informed when key events like regulatory clearances happen. MIB Alerts provide regular updates on clinical research and technology development in your areas of interest. Click here to learn more about our MIB Alerts - A Better Way...to stay up to date.

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• Gluten Free Diet - Celiac disease is particularly dangerous given the wide use of gluten in our daily diet. Breads, candies, soups even vitamins contain amounts of gluten. This site offers a listing of sources providing gluten free products.
  [www.celiac.com]

• Protein Wars - At the recent European Society of Cardiology meeting a study (ESC Congress 2007), findings were presented confirming that a protein conflict negates all heart health benefits of tea when milk was added. The culprit? Caseins. [www.escardio.org]

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MIB NewTips October 2007 Issue – Volume 2, Number 9

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