Cardiva Medical, Inc. to Present at the UBS 2007 Global Life Science Conference With the Announcement of FDA 510(K) Clearance of its Newest Device: The Boomerang Catalyst II System(TM)
Approved for both diagnostic and interventional procedures, Cardiva firstintroduced the original Boomerang Wire System in May 2005. While continuingto evolve its portfolio to meet the needs of its customers, Cardivasuccessfully enhanced the Boomerang Wire System in early 2007 by adding aproprietary hemostatic material to the spring-loaded section of the BoomerangWire which accelerates coagulation adjacent to the puncture site. Cardivalaunched this newly approved device in July as "Boomerang Catalyst System."The company has since enhanced the Boomerang Catalyst System to furtherimprove the clinical performance of the Boomerang technology by adding anadditional pro-coagulant to the proprietary hemostatic material of theCatalyst System. This new product will be released to the market under a tradename of "Boomerang Catalyst II System" in the fourth quarter of this year. Todate, the portfolio of Boomerang devices has been used in more than 80,000percutaneous catheterization procedures in the U.S.
During percutaneous catheterizations procedures, a catheter is threadedthrough the femoral artery to the site of vascular disease (most common is inthe heart), where diagnosis and/or treatment (such as stenting or angioplasty)can be performed. Traditionally, doctors have used two primary methods toclose the femoral artery puncture site: direct manual compression over thepuncture site or one of the various implantable vascular closure devices,which use materials (such as collagen, sutures, or staples) to create aphysical seal of the puncture site.
There are considerable drawbacks to current approaches. Specifically,manual management of the puncture site requires significant hospitalresources, may require several hours of bed-rest, and may result in bleeding-related complications as well as vessel scarring; while vascular closuredevices achieve hemostasis in minutes, they have been associated withcatastrophic complications and are not suitable for certain patients.Importantly, the Boomerang technology addresses all of these shortcomings.
The Company also announced preliminary results of its Boomerang CatalystII study at the New Cardiovascular Horizons meeting in New Orleans onSeptember 5. The Boomerang Catalyst II study is a multi-center, prospective,randomized controlled study comparing the Boomerang Catalyst II System tomanual compression, the "gold standard," across 550 patient participants. Thestudy demonstrated that those patients in the Boomerang arm had a 71.2% loweroverall complication rate and were able to ambulate 2.8 hours (55%) soonerthan the manual compression patients. Additionally, all patients in thediagnostic Boomerang Catalyst II cohort successfully achieved final hemostasisin the cath lab. "These results support the significant advancement theBoomerang Catalyst device represents over traditional manual compression,"noted Dr. Ron Smalling MD, one of the lead Investigators in the study.
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