Healthcare Industry News:  Side Branch Stent 

Devices Interventional Cardiology

 News Release - December 6, 2006

New Bifurcation Stent System Provides Breakthrough in Treatment of Ostial-Bifurcated Lesions

Sideguard(TM) Bifurcation Stent System from Cappella, Inc. yields excellent angiographic results and good wall apposition in initial clinical implantations.

AUBURNDALE, Mass.--(HSMN NewsFeed)--Cappella Inc. announced today the successful implantation of its Sideguard(TM) dedicated Side Branch Stents in two patients. The procedures were performed by Professor Eberhard Grube, MD, Chief of Cardiology and Angiology at the Heart Center Siegburg, Germany.

"The successful implantation of the Sideguard(TM) stents in human patients is a breakthrough in the treatment of ostial-bifurcated lesions," stated Professor Grube. "The Sideguard(TM) bifurcation stent system, which incorporates Cappella's smart balloon-sheath SE delivery technology, allows for flawless advancement, positioning, and delivery of the Sideguard(TM) stent to the side branch ostium. This resulted in excellent angiographic results and very good wall apposition."

According to Professor Grube, the ability to deliver Sideguard(TM) over a separate wire to the side branch ostium first, and then independently delivering a Cypher stent in the main branch significantly simplified the bifurcation procedure. He noted it was similar to performing a provisional stenting procedure, without leaving the side branch ostium unprotected.

Professor Grube added that "Today there is disagreement among clinicians when comparing provisional stenting and the two-stent approach. We are overwhelmed by conflicting studies as to which strategy is better. The Sideguard seems to present the most logical compromise between the two approaches." Furthermore, Professor Grube believes that Cappella's smart balloon-sheath SE delivery technology could have other vascular applications that could open the door to significant opportunities for self-expanding stents.

Mark Steckel, Ph.D., Cappella's VP of R&D pointed to the successes observed in the porcine survival studies. "These early case have confirmed our pre-clinical experience with the Sideguard(TM) in terms of ease of deliverability and excellent acute results over a wide range of bifurcation angles and vessel diameters. Neointimal thickness formation in the Sideguard(TM) stented segment was equivalent to the main branch where Cypher stents were used. As expected, we observed better injury scores with the self-expanding Sideguard(TM) as compared to the injury scores seen in the main branch stented with Cypher."

"We are pleased to have had the opportunity to collaborate with professor Grube to validate the superior performance of our Sideguard stent" said Guy Neev, Cappella's CEO. According to Neev, the successful implantation of Sideguard(TM) OPDs(TM) in humans "validates the ease of use and practicality of our technology." The Sideguard system incorporates three components: an anatomically-shaped stent, a novel self-expanding balloon deployable stenting system, and a proprietary polymer-free drug program. Neev believes that once the Sideguard(TM) is coated with a drug and tested, excellent long-term clinical results will be observed.

With Sideguard(TM) successfully implanted in humans, Cappella will focus on its first-in-man study, which will enroll 30 patients. Study endpoints include acute angiographic success and MACE at 30 days. Cappella expects to present some of its FIM acute angiographic and IVUS data, in addition to performing a Live Case at the Joint Interventional Meeting (JIM) 2007 in Rome, Italy in February.

About Cappella

Cappella is committed to developing novel coronary stent technologies designed to treat bifurcated and ostial lesions. The Sideguard(TM) Bifurcation Stenting System will be the first drug-eluting Side Branch Stent in interventional cardiologists' arsenal against restenosis for ostial-bifurcation lesions. The stent's nitinol frame allows Sideguard(TM) to be pre-shaped. The Sideguard(TM) Bifurcation Stenting System has a unique balloon-assisted delivery system for precise deployment.

For more information on Cappella or the Sideguard(TM) Side Branch Stent technology, please visit www.cappella-inc.com.


Source: Cappella

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