PLEASANTON, Calif., Sept. 3 /PRNewswire-FirstCall/ -- Advanced Stent Technologies (AST), Inc., received FDA conditional approval to incorporate its bare metal novel PETAL(TM) coronary bifurcation stent and delivery system into its ongoing U.S. BOSS clinical trial on August 13, 2004 and has enrolled the first patient by Dean J. Kereiakes, M.D. at the Lindner Clinical Trial Center in Cincinnati, Ohio.
AST will immediately initiate three other clinical centers to utilize the PETAL(TM) stent system. The centers are Elyria Memorial Hospital, Elyria, OH, Scripps Memorial Hospital, La Jolla, CA, and Stanford University Medical Center, Stanford, CA.
The conditional approval specifies enrollment of up to 30 nonrandomized patients using the PETAL(TM) stent system. AST is currently responding to FDA questions to gain full approval for enrollment of up to 100 PETAL(TM) patients. AST anticipates adding an additional four to six centers in the next several months.
The company has previously enrolled patients into the BOSS trial using SLK-View(R) stent system, which features a side branch aperture lacking ostial elements and is the predecessor to the PETAL(TM) stent system. The PETAL(TM) stent system incorporates innovative "petal" strut elements that deploy approximately two millimeters into the side branch vessel, physically supporting and covering the carina and side branch ostium in a circumferential manner, while at the same time providing continuous and unimpeded access to the side branch through the side aperture created by the deployment of the "petal" strut elements. Many key interventional thought leaders believe the combination of stent ostial coverage with unrestricted access to the side branch will lead to improved acute and long-term outcomes for this complex lesion subset. AST believes that the PETAL(TM) stent system is potentially applicable to up to 25 percent of all percutaneous coronary interventions.
The BOSS study Principal Investigator, Dr. Maurice Buchbinder of Scripps Memorial Hospital in La Jolla, CA, comments that the AST PETAL(TM) stent system "is a significant advancement toward solving many of the inherent issues of bifurcation stenting" and that "the PETAL(TM) stent system likely will prove to be the optimal platform for bifurcation drug-delivery, as is now the standard of care for addressing non-bifurcation coronary lesions".
AST is a developer and manufacturer of dedicated bifurcation stent technology. For more information, please visit http://www.advancedstent.com/ .
Advanced Stent Technologies Inc.