Cappella to Present a Live Case and Results from Coronary Bifurcation Stent Pre-Clinical Studies at TCT 2006.WASHINGTON -- Cappella Inc., developer of advanced stenting systems for the treatment of coronary bifurcation Bifurcation A term used in finance that refers to a splitting of something into two separate pieces. Notes: Generally, this term is used to refer to the splitting of a security into two separate pieces for the purpose of complex taxation advantages. disease announced today that it will participate in a live animal case featuring the Sideguard[TM] side branch stent, and will present results of its successful pre-clinical studies at the Cardiovascular Research Foundation's (CRF CRF abbr. chronic renal failure CRF Chronic renal failure ) eighteenth annual Transcatheter Cardiovascular Therapeutics (TCT TCT The Capital Times (Madison, WI newspaper) TCT Transcatheter Cardiovascular Therapeutics TCT The Coroner's Toolkit TCT Trans Canada Trail TCT Tcl Core Team TCT Tsukuba College of Technology (Japan) ) scientific symposium. "Our pre-clinical experience confirms the potential benefits of an anatomically-shaped, self expanding-stent for a coronary side branch" said Mark Steckel, Ph.D. Cappella's Vice President of R&D. "We have shown strut-wall apposition apposition /ap·po·si·tion/ (ap?o-zish´un) juxtaposition; the placing of things in proximity; specifically, the deposition of successive layers upon those already present, as in cell walls. by IVUS IVUS Intravascular ultrasound, see there that will be very challenging for existing balloon-expandable, tubular stents to achieve. Recent data suggests a link exists between late incomplete strut apposition and the incidence of late stent thrombosis late stent thrombosis Cardiology The scar-induced closure of a previously stenosed coronary artery, a complication in ±20% of Pts who have undergone stenting for CAD. See Stent. Cf In-stent restenosis. . We believe that the self-expanding Sideguard[TM] platform may have intrinsic safety benefits." noted Dr. Steckel. According to Michael Jonas, M.D. of Harvard-MIT's Division of Health Science & Technology and a Sideguard[TM] pre-clinical study investigator, "IVUS confirmed completed coverage of both the side and main branches when the Sideguard[TM] side branch stent and a Cypher See cipher. main branch stent were used together. This indicates that once deployed, Sideguard[TM] provides full and seamless apposition through the entire bifurcated bi·fur·cate v. bi·fur·cat·ed, bi·fur·cat·ing, bi·fur·cates v.tr. To divide into two parts or branches. v.intr. To separate into two parts or branches; fork. adj. stented segment." "We are pleased to be able to present the results from our animal studies and to have the opportunity to demonstrate the capabilities of our side branch stent and ostium ostium /os·ti·um/ (os´te-um) pl. os´tia [L.] an opening or orifice.os´tial ostium abdomina´le tu´bae uteri´nae protection device during a live case at TCT," said Guy Neev, Cappella's CEO (1) (Chief Executive Officer) The highest individual in command of an organization. Typically the president of the company, the CEO reports to the Chairman of the Board. . "The completion of our animal trials clears the way for the Sideguard[TM] first-in-man study, which we expect to begin following TCT." Cappella will file its first-in-man application for the Sideguard[TM] FIM FIM The ISO 4217 currency code for the Finnish Markka. study next week in Germany. Neev added that "We have just launched our drug eluting program with an exciting and unique technology, which we believe is likely to address some of the major safety concerns associated with late stent thrombosis." "Safety is a growing concern with coronary stents, particularly the occurrence of stent thrombosis," stated Dr. Steckel. "We believe the Sideguard[TM] stent's design is better suited to address the stent thrombosis risk. The stent's self-expanding feature minimizes trauma following deployment and virtually eliminates flow disturbances, usually caused by stent malapposition and intricate stenting techniques. In comparison, Sideguard's[TM] nitinol frame conforms to the anatomy of the artery once deployed." Cappella will be presenting its results from the Sideguard[TM] Bifurcation Stenting System porcine survival studies during a presentation by Professor Antonio Colombo, the renowned international expert in coronary bifurcation disease, of Columbus Hospital in Milan, Italy. Cappella's live animal case is being performed by Dr. Jonas where he will utilize the Sideguard [TM] Bifurcation Stenting procedure to treat a coronary bifurcated lesion. Cappella/Sideguard[TM] Scheduled Events - Wednesday, Oct. 25 1 8:00 AM (ET) - Sideguard[TM] Live Case in the Coronary Theater; Dr. Michael Jonas 2 12:17 PM (ET) - The Cappella Sideguard Stent in room 145AB ; Prof. Antonio Colombo Cappella will have the latest information available on Sideguard[TM] at booth 151 in the Emerging Technologies Area in the main Exhibit Hall. Members of Cappella's Executive team will be available during exhibit hours. About Cappella Cappella is focused on developing novel coronary stent technologies designed to treat bifurcated lesions. The Sideguard[TM] Bifurcation Stenting System will be the first drug-eluting side branch, ostium protection device (OPD OPD Tape symbol showing either the first transaction of the day in a security after a delayed opening or the opening transaction in a security whose price has experienced a large rise or fall from the previous day's closing price. ) [TM] 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. Pre-clinical studies have demonstrated that the stent is easy to deliver, has produced favorable angiographic results, and its seamless apposition makes it an appealing drug delivery platform. Cappella will begin its First-In-Man (FIM) clinical trials shortly following TCT, enrolling 30 patients at three sites in Europe. For more information on Cappella or the Sideguard[TM] side branch stent technology, please visit www.cappella-inc.com or contact Mark Paquin at mark.paquin@cappella-inc.com or at 813-841-0366. Regulatory notice: The Sideguard[TM] Bifurcation Stenting System and the Sideguard[TM] OPD[TM] are investigational devices and are not yet available for sale in the U.S. |
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