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)

Thursday, September 20, 2007 General News
Email Print This Page Comment bookmark
Font : A-A+

MOUNTAIN VIEW, Calif., Sept. 20 Cardiva Medical, Inc., aprivately held medical device company, announced today that Augustine Lien,Chairman and CEO, will present at the UBS 2007 Global Life Science Conferenceon Tuesday, September 25th in New York City. Notably, the company will bepositioned to share information on its newest device, the Boomerang CatalystII System, which recently received a 510(K) US market clearance. This newproduct builds on the success of its predecessor, the Boomerang CatalystSystem TM, which launched in July 2007 with fast acceptance from cardiaccenters across the U.S. given its unique product profile. Specifically, boththe Boomerang Catalyst System and Boomerang Catalyst II System are the firstvascular closure devices to achieve final hemostasis in the catheterizationlab without leaving any foreign materials behind in the vessel, therebyeliminating a major cause of device failures, complications and re-accesschallenges.

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.

Post your Comments

Comments should be on the topic and should not be abusive. The editorial team reserves the right to review and moderate the comments posted on the site.
* Your comment can be maximum of 2500 characters
I agree to the terms and conditions

News A - Z


News Search

Medindia Newsletters

Subscribe to our Free Newsletters!

Terms & Conditions and Privacy Policy.

Find a Doctor

Press Release Category

Press Release Archive

Stay Connected

  • Available on the Android Market
  • Available on the App Store