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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)
Date:9/20/2007

cedures in the U.S.

During percutaneous catheterizations procedures, a catheter is threaded through the femoral artery to the site of vascular disease (most common is in the heart), where diagnosis and/or treatment (such as stenting or angioplasty) can be performed. Traditionally, doctors have used two primary methods to close the femoral artery puncture site: direct manual compression over the puncture site or one of the various implantable vascular closure devices, which use materials (such as collagen, sutures, or staples) to create a physical seal of the puncture site.

There are considerable drawbacks to current approaches. Specifically, manual management of the puncture site requires significant hospital resources, may require several hours of bed-rest, and may result in bleeding- related complications as well as vessel scarring; while vascular closure devices achieve hemostasis in minutes, they have been associated with catastrophic 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 Catalyst II study at the New Cardiovascular Horizons meeting in New Orleans on September 5. The Boomerang Catalyst II study is a multi-center, prospective, randomized controlled study comparing the Boomerang Catalyst II System to manual compression, the "gold standard," across 550 patient participants. The study demonstrated that those patients in the Boomerang arm had a 71.2% lower overall complication rate and were able to ambulate 2.8 hours (55%) sooner than the manual compression patients. Additionally, all patients in the diagnostic Boomerang Catalyst II cohort successfully achieved final hemostasis in the cath lab. "These results support the significant advancement the Boomerang Catalyst device represents over traditional manual compression," noted Dr. Ron Smalling MD, one of the lead Investigators in the study. "In
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SOURCE Cardiva Medical, Inc.
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