MOUNTAIN VIEW, Calif., Sept. 20 /PRNewswire/ -- Cardiva Medical, Inc., a privately held medical device company, announced today that Augustine Lien, Chairman and CEO, will present at the UBS 2007 Global Life Science Conference on Tuesday, September 25th in New York City. Notably, the company will be positioned to share information on its newest device, the Boomerang Catalyst II System, which recently received a 510(K) US market clearance. This new product builds on the success of its predecessor, the Boomerang Catalyst System TM, which launched in July 2007 with fast acceptance from cardiac centers across the U.S. given its unique product profile. Specifically, both the Boomerang Catalyst System and Boomerang Catalyst II System are the first vascular closure devices to achieve final hemostasis in the catheterization lab without leaving any foreign materials behind in the vessel, thereby eliminating a major cause of device failures, complications and re-access challenges.
Approved for both diagnostic and interventional procedures, Cardiva first introduced the original Boomerang Wire System in May 2005. While continuing to evolve its portfolio to meet the needs of its customers, Cardiva successfully enhanced the Boomerang Wire System in early 2007 by adding a proprietary hemostatic material to the spring-loaded section of the Boomerang Wire which accelerates coagulation adjacent to the puncture site. Cardiva launched this newly approved device in July as “Boomerang Catalyst System.” The company has since enhanced the Boomerang Catalyst System to further improve the clinical performance of the Boomerang technology by adding an additional pro-coagulant to the proprietary hemostatic material of the Catalyst System. This new product will be released to the market under a trade name of “Boomerang Catalyst II System” in the fourth quarter of this year. To date, the portfolio of Boomerang devices has been used in more than 80,000 percutaneous catheterization procedures 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 particular, the ability to achieve final hemostasis in the catheterization lab for diagnostic patients while reducing the overall complication rate will yield important cost savings to the institutions.” Dr. Smalling continued, “The Catalyst II device promises to build upon the already impressive clinical achievements of its predecessor. The Boomerang technology has consistently shown that by leaving nothing in the tissue tract or artery, implant-related complications, which plague current vascular closure devices, are eliminated while immediate and future re-access to the vessel is preserved.”
Both Boomerang Catalyst System devices, along with the innovative supporting resources in Cardiva’s Pathway Program, uniquely provide clinicians with the control to achieve rapid hemostasis in the short term with the confidence of safety in the long term, enabling clinicians to go beyond closure to deliver the greatest benefit to patients, nurses, and physicians in and out of the cath lab. “Easy to use, the Boomerang Catalyst System is a significant advancement in the cath lab in terms of enabling rapid hemostasis with early ambulation for nearly all patients without associated complications. The successful adoption of our product demonstrates that the Catalyst System delivers where other approaches fail, yielding unprecedented clinical safety and economic outcomes. With the market approval of the Boomerang Catalyst II System, we are excited about the upcoming launch of this new product, and expect to expand the breadth and depth of benefits demonstrated with the Boomerang Catalyst System,” said Augustine Y. Lien, founder, Chairman and Chief Executive Officer of Cardiva Medical.
About the family of Boomerang Catalyst System devices
At the end of the percutaneous procedure, the thin Boomerang Catalyst System is inserted into the artery through the existing arterial sheath used during the catheterization procedure. Once inside the artery, the Boomerang device opens a flat, low-profile disc. Upon removal of arterial sheath, the Boomerang disc is positioned against the opening of the femoral artery forming a tight seal from inside of the vessel. The proprietary coating on the wire stimulates the coagulation cascade, which combined with the tight seal, accelerates hemostasis. This cascade is further accelerated with the addition of the pro-coagulant to the wire on the Boomerang Catalyst II System.
After dwelling, the Boomerang disc is collapsed and completely removed from the artery, leaving nothing behind in the tissue tract or artery. Final closure occurs with just a few minutes of finger pressure on the arterial puncture site and can be achieved in the cath lab for diagnostic patients.
About Cardiva Medical, Inc.
Founded in July 2002, and headquartered in Mountain View, Calif., Cardiva Medical, Inc. is a privately held medical company focused on developing and commercializing vascular access site management and closure devices with unsurpassed safety and ease-of-use. Cardiva’s first product, the Boomerang Wire System, was approved in EU countries and in the US in 2004 and brought to market in 2005. The second-generation product, the Boomerang Catalyst System, was approved in March 2007 and launched in July 2007. The enhanced Boomerang Catalyst, trade named as “Boomerang Catalyst II System”, has received 510(K) clearance in September 2007, and will launch to the market in the fourth quarter this year. The company is committed to going beyond closure with both Boomerang Catalyst System devices, which uniquely provide: control to achieve rapid hemostasis with early patient ambulation; confidence to leave nothing behind, eliminating implant-related complications and enabling immediate re- access; and complementary resources in Cardiva’s Pathway Program, which support clinicians in and out of the cath lab. Because of its unique focus and outstanding technology, Cardiva was selected by Frost & Sullivan as the recipient of the 2006 Frost & Sullivan Award for Entrepreneurial Company in the U.S. angioplasty and vascular closure devices market. Cardiva Medical, Inc. is funded by leading venture capital investors, including Galen Partners, Stockton Partners, Sycamore Ventures, Harbinger Venture Corp., and W.I. Harper Group. Additional information about Cardiva Medical, Inc. can be found on http://www.cardivamedical.com.
Cardiva, Boomerang and Boomerang Catalyst System are trademarks/registered trademarks of Cardiva Medical, Inc.
Media Contacts: Glenn Foy, President Cardiva Medical, Inc. Phone: 650.964.8900, x 215 Fax: 650.964.8911 glenn_foy@cardivamedical.com
Cardiva Medical, Inc.
CONTACT: Glenn Foy, President of Cardiva Medical, Inc., +1-650-964-8900,ext. 215, fax, +1-650-964-8911, glenn_foy@cardivamedical.com
Web site: http://www.cardivamedical.com/
