A Medical Device Daily

Cardiovascular stent maker Tryton Medical (Research Triangle Park, North Carolina) has reported the European launch of its Side Branch Stent System, which is designed to treat atherosclerotic lesions at the site of a bifurcation.

Tryton's cobalt chromium stent is deployed in the side branch artery using a standard single-wire balloon-expandable stent delivery system. A conventional drug-eluting stent is then placed in the main vessel. The company said that about 20% of patients treated for coronary artery disease are treated for bifurcated lesions.

The launch was announced at a meeting of the European Bifurcation Club in Prague, Czech Republic.

The system will be available first in the Netherlands, with additional European countries to follow in the coming months. TOP Medical is the distributor for the device in the Netherlands.

J. Greg Davis, president/CEO of Tryton Medical, said, "We are excited about the benefits that our technology promises for patients with cardiovascular disease in Europe. We plan to launch in additional countries soon."

He added that the company plans to initiate a multi-center prospective study evaluating the Tryton Side Branch Stent in real-life practice in the coming weeks.

The company noted that bifurcation lesions have presented a challenge for cardiologists since the earliest days of angioplasty, saying that "current approaches to treating these lesions have significant limitations." As a result, it said, "the side branch is often left unstented, leaving it vulnerable to higher rates of restenosis, the re-narrowing of the stented vessel following implantation."

Antonio Bartorelli, MD, of the Centro Cardiologico Monzino at the University of Milan in Italy, said, "The Tryton Side Branch Stent System, which has demonstrated excellent initial clinical results, offers an innovative solution to a persistent problem in the interventional treatment of patients with complex coronary lesions. I am pleased that this highly deliverable side-branch stent is now available as a treatment option for these difficult-to-treat cases."

New Paris training center for Boston Sci

Boston Scientific (Natick, Massachusetts) reported the grand opening of its International Institute for Therapy Advancement in Paris. The institute is focused on providing training and education to help healthcare professionals advance the standard of patient care.

The 3,000-square-meter facility offers what the company termed "the latest in modern medical training and current clinical science focused on cardiac and vascular therapies." The grand opening was attended by leading European electrophysiologists.

"The pace of innovation and the volume of clinical data make it difficult for healthcare professionals to master new procedures and focus on essential advancements in their field," said Panos Vardas, MD, of the cardiology department at the University Hospital of Heraklion (Crete, Greece) and president-elect of the European Heart Rhythm Association. "The Institute for Therapy Advancement recognizes this challenge and is committed to helping physicians develop the latest skills and techniques that can impact clinical practice and create immediate value for patients and the healthcare community."

The institute offers training that combines practical skills development with the latest evidence-based clinical science. It features the latest in equipment, fully functional catheterization labs, virtual reality simulators and modern classrooms with satellite capacity for live-case observation.

Boston Sci said, "Clinical programs are designed and taught by independent physician experts and opinion leaders who ensure the scientific quality of teaching content." Current courses are offered in cardiac rhythm management and heart failure management, with new courses beginning in 2009 covering interventional cardiology and peripheral interventions.

The Paris center is part of Boston Scientific's global medical education network, which includes facilities in St. Paul, Minnesota; Tokyo and Myasaki, Japan.

CE mark for SmoothShapes system

Elemé Medical (Merrimack, New Hampshire), a private venture-backed aesthetics company building a franchise in the body-shaping market with an initial focus on treatment of cellulite, reported receipt of CE-mark approval for its already FDA-cleared SmoothShapes System.

The company launched the SmoothShapes device at last week's 17th congress of the European Academy of Dermatology & Verenology in Paris. Elemé Medical sponsored a symposium featuring an international panel of dermatologists during the event.

The system uses a proprietary technology called Photomology, which features a mechanism of action combining dynamic laser and light energy with mechanical massage and vacuum. This process affects the fat cells and inflexible collagen responsible for the appearance of cellulite.

Elemé Medical said SmoothShapes "stimulates restoration of healthy cell activity by focusing on both the physical manifestations of cellulite and its underlying causes."

Nancy Briefs, president/CEO, said, "We anticipate that SmoothShapes will be able to quickly establish a solid traction in European markets.