Healthcare Industry News: Sideguard
News Release - November 5, 2007
At TCT 2007, Cappella Demonstrates Procedural Advantages and Clinical Benefits of Its Technology in Treating Coronary BifurcationsCompany Also Announces Engagement with Cowen & Company As Its Exclusive Financial Advisor
"…Cappella has only scratched the surface in terms of the adaptability, application, and unique delivery system for its nitinol platform." -- Martin B. Leon, M.D., Cappella's Chief medical officer and Co-Founder of the TCT conference.
AUBURNDALE, Mass., Nov 5--(HSMN NewsFeed)--Cappella Inc., developer of breakthrough solutions for coronary artery disease (CAD), participated in the Cardiovascular Research Foundations' nineteenth annual “Transcatheter Cardiovascular Therapeutic” (TCT) 2007 scientific symposium that took place from October 21 through October 26 in Washington, D.C.
“TCT was a very impressive meeting for Cappella. We had three well-attended presentations, two of which discussed our stent platform and reviewed our favorable clinical results, and the other presented our novel macromolecular ProDrug technology, Cappella's proposed solution to many drug eluting stent questions,” said Cappella President and CEO, John A. Williams.
Professor Eberhard Grube, Chief of Cardiology and Angiology at the HELIOS Heart Center, presented 6 month follow-up data from Cappella's First-In-Man (FIM) clinical trial on behalf of the German and Belgium investigator team. “The safety and efficacy data at follow-up from this initial cohort are truly remarkable even when compared to earlier drug eluting stent studies for treating coronary bifurcations” commented Prof. Grube. When asked by a TCT panel member to what he attributed the favorable outcomes to, Professor Grube replied, “Cappella's nitinol design provides unmatched scaffolding of the entire bifurcation segment, excellent strut wall apposition, low injury deployment, and minimum metal overlap in the main vessel. Their stent design and balloon-actuated delivery system appear to be a significant step forward.”
“Our results in most cases were superior to those observed when one and two conventional DES [drug-eluting stents] have been used to treat bifurcations,” John Williams said. This sentiment was echoed by both Dr. Martin B. Leon and Prof. Grube, who agreed that there really has been no “easy-to-use clinically superior solution” for bifurcations. “Late loss results of 0.24 mm and net luminal gains of more than two millimeters in the side branch, particularly in heavily diseased bifurcations, have been observed in the Sideguard FIM study, and not in studies involving two drug eluting stents. These results are even more impressive because Cappella's Sideguard is a bare metal stent,” added Prof. Grube.
“We believe that nitinol is the next generation of bifurcation stenting and a possible solution to the treatment of many more types of complex coronary lesions,” explained Martin B. Leon, MD, Cappella's Chief Medical Officer and co-founder of the TCT conference. “A lot more is understood about nitinol and its use in the treatment of coronary artery disease since it was first used in the coronaries over a decade ago. TCT provided a platform to demonstrate the ease-of-use, safety, and efficacy of a uniquely designed nitinol side branch stent as a treatment for coronary bifurcations. Opportunities are plentiful for the use of nitinol in treating CAD, and Cappella has only scratched the surface in terms of the adaptability, application, and unique delivery system for its nitinol platform.”
The culmination of Cappella's very successful TCT participation was a “live” case performed at Prof. Grube's clinic in Siegburg, Germany and broadcast to the convention via satellite. This was a ground-breaking case for Cappella, as Prof. Grube selected the newly CE-Marked Endeavor Resolute cobalt-alloy drug eluting stent (Medtronic Vascular) to be used with the Sideguard. “The ability to use these two novel technologies to treat bifurcations reflects that significant progress has been made in interventional cardiology,” explained Prof. Grube.
A Cappella procedure begins with the placement of guidewires in the side and main branches, after which the Sideguard is advanced and deployed in the side branch, followed by the placement of any conventional workhorse stent in the main branch. “The Sideguard procedure is unparalleled for treating bifurcations,” Prof. Grube added. Placing and deploying the device is easy because Sideguard is delivered independently from the main vessel stent. This eliminates the risk of wire braiding, a problem observed with other dedicated bifurcation stent technologies.
According to Prof. Grube, re-accessing the side branch is easy once the main vessel stent is placed. “Furthermore, the stent architecture provides a smooth transition throughout the bifurcation segment, --most importantly at the carina--and there is less than a millimeter of stent strut overlap in the main vessel.” All of these factors, Prof. Grube pointed out, significantly improve blood flow and reduce flow disturbances, drastically lessening the chances of thrombotic events.
Cappella also announced that it has retained Cowen and Company to serve as Financial Advisors to ensure that Cappella has sufficient capital to successfully complete critical milestones, such as its CE trial, the launch of the Sideguard in Europe, and the commencement of clinical trials and launching of Sideguard in the United States. “It is very heartening to be working with an organization as highly respected as Cowen and Company. With their help, we will raise the capital required that will allow us to bring our unique platform to interventional cardiologists on a world wide basis,” John Williams said.
Cappella has developed a novel solution for the treatment of ostial and bifurcated disease. In contrast to current approaches for treating bifurcations, Cappella's Sideguard OPD™ (Ostium Protection Device) conforms to the anatomy of the bifurcated segment. The Sideguard OPD™ has demonstrated ease of use and excellent clinical results. Cappella believes its technology is uniquely suited to the complexities associated with bifurcations.
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