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Sara Conley
Tim LeRoy
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EMBARGOED UNTIL JANUARY 28, 2007

EMBARGOED FOR RELEASE UNTIL SUNDAY, JANUARY 28 AT 8 A.M.

ISET News Briefs
Scientific Sessions, Clinical Reviews and Trial Updates

(January 28, 2007) – In addition to presentations described in news releases from the 19th Annual International Symposium on Endovascular Therapy (ISET), the following reports delivered at the symposium have been identified as newsworthy.

New Embolic Agent for Treating Liver Cancer

James Benenati, M.D. (Baptist Cardiac & Vascular Institute, Miami), reviews clinical experience with two recently approved embolic agents for embolization of primary and secondary liver cancers. HepaSphere and Quadrasphere (Biosphere Medical, Inc., Rockland, Md.) are super-absorbent polymers (SAP) capable of absorbing more than 500 times their weight when dissolved in non-ionic solution. They provide predictable flow, conforming to the walls of the vessel lumen and resulting in a sufficient contact area for occlusion of the vessel.

HepaSphere appeared to have better conformity. In a study of six patients with a total of nine liver cancer nodules who underwent transarterial embolization with HepaSphere, complete necrosis was observed in three nodules, nearly complete necrosis in three nodules and partial necrosis in three nodules, with only minimal pain reported and no deterioration in liver function. In Europe, recent clinical experience (158 cases) shows complete necrosis in 57 percent of patients treated, partial necrosis in 18 percent and incomplete necrosis in 25 percent.

Ultrasound-enhanced Clot Buster Gets Patients Out of Hospital Faster

Thomas McNamara, M.D. (University of California at Los Angeles), is presenting data on 111 patients treated for blood clots in pelvic or leg arteries with ultrasound-enhanced delivery of clot-busting drugs. The ultrasound-enhanced system dissolved the clot quicker than standard delivery of clot-busting drugs: 18.5 hours vs. 24.4 hours. The end result is patients typically leave the hospital a day earlier after ultrasound-enhanced delivery of clot-busting drugs vs. standard delivery. The device enhances delivery of the drugs via tiny rice-sized ultrasound transducers situated on a wire that is advanced to the site of the clot. The transducers emit high-frequency, low-energy ultrasound waves that loosen up the fibers of the clot, as well as force the drug into the clot so that it dissolves faster.

CoreValve Trial Update

Eberhard Grube, M.D. (Heart Center Siegburg, Germany), reports the experience of high-risk patients unsuitable for surgery who underwent percutaneous aortic valve replacement (PAVR) as an alternative to palliative medical therapy for severe aortic stenosis. Drawing data from 39 procedures performed successfully, Dr. Grube found that PAVR with the self-expandable CoreValve prosthesis (21 French version and even more the new 18 French version) is feasible and safe; successful procedures result in marked hemodynamic and clinical improvement, which was sustained at 15 months.

In the first generation, the approach involved general anesthesia, surgical peripheral arterial access and femoral vein-femoral artery cardiopulmonary bypass; when the 18 French prosthesis is used, there is no more need for surgical preparations, cardiopulmonary bypass or general anesthesia. PAVR is on its way to becoming a stent-like procedure, according to Dr. Grube.

Prevention of Restenosis with Drug-Coated Balloons

Gunnar Tepe, M.D. (University of Tuebingen, Germany), reports research suggesting that paclitaxel-coated balloons could significantly reduce the rate of restenosis after percutaneous transluminal angioplasty (PTA) in the superficial femoral artery (SFA) and in the popliteal artery. Data includes outcomes of 102 patients enrolled to receive treatment of stenosis or occlusion of the SFA and/or popliteal artery with either a bare or coated balloon. The primary efficacy endpoint of the study was the late lumen loss of the target lesion, directly post-intervention and at a six-month follow-up.

Most Failures in Carotid Artery Stenting are Preventable

Juan Carlos Parodi, M.D. (University of Miami), is presenting data from Washington University on 213 cases of carotid artery stenting (CAS) that resulted in five strokes (2.3 %), all ischemic and minor. Expanding on the details of each case, Dr. Parodi is reporting that the strokes might have been prevented had attending physicians: avoided crossing catheters over severe lesions; chosen cerebral protection devices (CPDs) and stents according to anatomy and plaque morphology; and selected appropriate anticoagulation agents and different styles of catheters.

Uterine Fibroid Embolization (UFE) is a Viable and Widely Utilized Treatment Option for Women with Symptomatic Uterine Fibroids

According to a clinical update being presented by Howard Chrisman, M.D. (Northwestern Medical Faculty Foundation, Chicago), recent experience suggests that a thoughtful, collaborative approach to UFE is a safe and effective treatment for women of child-bearing age who wish to maintain their fertility.

Considered to be the premier meeting on endovascular therapy, the International Symposium on Endovascular Therapy (ISET) is attended by more than 1,200 physicians, scientists and industry professionals from around the world, as well as several hundred industry representatives. The meeting pioneered the use of live cases to promote the multidisciplinary treatment of vascular disease. ISET is presented by the Baptist Cardiac & Vascular Institute, Miami.