Evolutionary Percutaneous Access Management Device is Safe, Easy
to Use and Improves Manual Compression Efficiency
Cardiva Medical, Inc., a privately held medical device company, announced that it will be presenting at 9:30 A.M. on February 24 at Medtech Insight and Windhover Information's "Investment In Innovation (In3) WEST: A Preview of Early-Stage Medical Technology Companies" Conference, February 23-24, 2006 at the Hyatt Regency Irvine in Irvine, California. Cardiva Medical, Inc. ("The Company") received clearance from the U.S. Food and Drug Administration ("FDA") to market the Boomerang(TM) Percutaneous Access Management System ("Boomerang (TM)") in November 2004. The Boomerang(TM) Wire is cleared to assist clinicians in closing femoral artery punctures sites following the most common percutaneous procedures, such as diagnostic angiography, angioplasty, and stenting. The Company has been actively marketing the Boomerang(TM) device through its direct sales force and has seen tremendous success in the market since its product launch about a year ago.
Millions of percutaneous catheterizations are performed world-wide each year, with approximately 80% of such procedures being diagnostic angiography. During percutaneous catheterization procedures, the 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 various methods to close the femoral artery puncture site, including direct manual or mechanical compression over the femoral puncture site or one of the implantable vascular closure devices, which use various biomaterials (such as collagen, gels, sutures, or staples) to create a physical seal of the femoral artery puncture site.
Direct manual compression can be quite painful for the patient and may require several hours of bed-rest to achieve complete hemostasis; while implantable vascular closure devices achieve hemostasis in minutes, but have been associated with catastrophic complications. Cardiva's Boomerang(TM) is designed to improve manual compression efficiency and to leave nothing behind in the femoral artery or at the puncture site, thereby avoiding the implantable closure device related complications.
Since the market clearance by the FDA in late 2004, more than 10,000 patients have been treated with the Boomerang(TM) device following percutaneous procedures. Clinical results from this large pool of post-market patients have demonstrated the excellent efficacy and safety, with virtually no major complications, of using the Boomerang(TM) device.
In practice, at the end of the percutaneous procedure, the Boomerang(TM) device is inserted into the artery through the existing arterial sheath used during the catheterization procedure. Upon removal of arterial sheath, the Boomerang(TM) disc is positioned against the opening of the femoral artery for a tight seal and immediate hemostasis in the cath lab. Once the patient arrives into the recovery room, the Boomerang(TM) disc is collapsed and the device is completely removed from the artery, leaving nothing behind in the tissue tract or artery following the Boomerang(TM) procedure, with final hemostasis achieved with a few minutes of manual compression.
Augustine Y. Lien, founder, Chairman and Chief Executive Officer of Cardiva, said, "We believe that the Boomerang(TM) device is not only far more comfortable and cost-effective for patients undergoing manual compression of the femoral artery opening, but also provides unsurpassed safety for patients and ease-of-use for medical practitioners when compared to existing implantable vascular closure devices. We are pleased and encouraged by rapid adoption of this new technology by the clinicians as the clinical and cost benefits of the Boomerang(TM) are becoming more obvious in their practices and more important to their patients."
A division of Windhover Information Inc., Medtech Insight is the leading provider of business information and market intelligence for the medical technology marketplace. In3 WEST is Medtech Insight's 20th investment and partnering event to date. To register to attend or for more information on Medtech Insight, please call Kristy Grimes at (480) 985-9512 or (888) 202-5939 toll-free in the U.S., e-mail kristy@medtechinsight.com, or visit www.medtechinsight.com.
Cardiva Medical, Inc., a privately held medical device company, announced that it will be presenting at 9:30 A.M. on February 24 at Medtech Insight and Windhover Information's "Investment In Innovation (In3) WEST: A Preview of Early-Stage Medical Technology Companies" Conference, February 23-24, 2006 at the Hyatt Regency Irvine in Irvine, California. Cardiva Medical, Inc. ("The Company") received clearance from the U.S. Food and Drug Administration ("FDA") to market the Boomerang(TM) Percutaneous Access Management System ("Boomerang (TM)") in November 2004. The Boomerang(TM) Wire is cleared to assist clinicians in closing femoral artery punctures sites following the most common percutaneous procedures, such as diagnostic angiography, angioplasty, and stenting. The Company has been actively marketing the Boomerang(TM) device through its direct sales force and has seen tremendous success in the market since its product launch about a year ago.
Millions of percutaneous catheterizations are performed world-wide each year, with approximately 80% of such procedures being diagnostic angiography. During percutaneous catheterization procedures, the 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 various methods to close the femoral artery puncture site, including direct manual or mechanical compression over the femoral puncture site or one of the implantable vascular closure devices, which use various biomaterials (such as collagen, gels, sutures, or staples) to create a physical seal of the femoral artery puncture site.
Direct manual compression can be quite painful for the patient and may require several hours of bed-rest to achieve complete hemostasis; while implantable vascular closure devices achieve hemostasis in minutes, but have been associated with catastrophic complications. Cardiva's Boomerang(TM) is designed to improve manual compression efficiency and to leave nothing behind in the femoral artery or at the puncture site, thereby avoiding the implantable closure device related complications.
Since the market clearance by the FDA in late 2004, more than 10,000 patients have been treated with the Boomerang(TM) device following percutaneous procedures. Clinical results from this large pool of post-market patients have demonstrated the excellent efficacy and safety, with virtually no major complications, of using the Boomerang(TM) device.
In practice, at the end of the percutaneous procedure, the Boomerang(TM) device is inserted into the artery through the existing arterial sheath used during the catheterization procedure. Upon removal of arterial sheath, the Boomerang(TM) disc is positioned against the opening of the femoral artery for a tight seal and immediate hemostasis in the cath lab. Once the patient arrives into the recovery room, the Boomerang(TM) disc is collapsed and the device is completely removed from the artery, leaving nothing behind in the tissue tract or artery following the Boomerang(TM) procedure, with final hemostasis achieved with a few minutes of manual compression.
Augustine Y. Lien, founder, Chairman and Chief Executive Officer of Cardiva, said, "We believe that the Boomerang(TM) device is not only far more comfortable and cost-effective for patients undergoing manual compression of the femoral artery opening, but also provides unsurpassed safety for patients and ease-of-use for medical practitioners when compared to existing implantable vascular closure devices. We are pleased and encouraged by rapid adoption of this new technology by the clinicians as the clinical and cost benefits of the Boomerang(TM) are becoming more obvious in their practices and more important to their patients."
A division of Windhover Information Inc., Medtech Insight is the leading provider of business information and market intelligence for the medical technology marketplace. In3 WEST is Medtech Insight's 20th investment and partnering event to date. To register to attend or for more information on Medtech Insight, please call Kristy Grimes at (480) 985-9512 or (888) 202-5939 toll-free in the U.S., e-mail kristy@medtechinsight.com, or visit www.medtechinsight.com.