Ashland, Ky. - Cardiologist Richard Paulus, M.D., received the first-ever "Chairman's Award" from Cardiva Medical, Inc., Tuesday, July 22, at 2 p.m., at a ceremony at the KDMC Heart and Vascular Center main lobby. Cardiva Medical is a privately owned medical device company headquartered in Mountain View, Calif., in the Silicon Valley. Augustine Lien, Cardiva founder, chairman, and chief executive officer, recognized Dr. Paulus for his “commitment to improving patient care through clinical and technological advancements.” Specifically, Dr. Paulus has made significant contributions toward design improvements of the Boomerang Catalyst™ System™.
The Boomerang® system is a new method used to close the femoral (leg) artery following a catheterization procedure. It has several advantages over other closure systems, namely that it helps stop bleeding quickly, leaves nothing behind in the patient, and produces minimal or no scarring.
“Dr. Paulus’ contributions and suggestions are having a national impact, and we have received positive feedback on the improved performance of the ‘Paulus disc’ from cardiologists around the country,” said Lien.
Paulus met with Cardiva representatives a few years ago at a national cardiology conference in Washington, D.C. He agreed to try their device, and soon afterward was discussing design improvements. The company incorporated his suggestions and produced 30 prototypes for Paulus to try. He was pleased with the changes, and the new device, referred to by company insiders as the “Paulus disc,” was tested at several other heart centers, where they were favorably received. The new disc has been in production for three months and now is being used by hospitals around the U.S.
Paulus recommended that the disc be made as a bi-convex shape rather than a flat round shape, to add strength and reduce the likelihood of gapping around the artery or of the disc slipping out of the puncture site. “Now it consistently has a good seal around the artery and we’re seeing better outcomes,” Paulus said. “The disc is kept in place a short time, then is collapsed and completely removed from the artery. Final closure occurs with just a few minutes of finger pressure on the puncture site.
“The Boomerang is my preferred closure device,” Paulus continued. “It fosters nature’s own healing process by jump-starting the natural clotting system, allowing the artery to recoil, and leaves nothing behind in the patient’s tissue tract or artery. I’m pleased I was able to provide input to further improve the Boomerang.”
Lien said Paulus has no financial incentives with the company and does not receive financial gain from the product improvement. “Dr. Paulus was interested in this device mainly because it is the first closure system to achieve hemostasis immediately after a catheterization procedure without leaving something in the artery, which is a great benefit to patients and families,” Lien said.
Millions of patients undergo diagnostic and interventional catheterization procedures each year; King’s Daughters performs more than 15,600 catheterization procedures annually. These minimally invasive procedures involve accessing coronary and peripheral blood vessels through an artery, most often the femoral artery. Once the procedure is complete, however, stopping the bleeding and closing the arterial puncture site, or arteriotomy, remains a challenge.
Common closure methods include manual compression, which requires the patient to lie in bed for several hours without bending their leg; or using a vascular closure device such as mechanical closure with sutures, collagen, clips, gels or implanted devices. Complications that may occur with these methods can include: recurrence of bleeding; embolisms; vessel scarring at the puncture site, which can make it difficult and painful during future catheter procedures; tissue growth at the puncture site that can lead to blood flow problems in the legs; hematomas; infection; or the body rejecting foreign materials left at the puncture site.
Recognizing the need to provide clinicians with an improved approach to managing and closing access sites, Cardiva Medical, Inc. was founded in July 2002. Cardiva's first product, the Boomerang® Wire™, was approved in the E.U. and in the U.S. in 2004, and brought to market in 2005. Its second-generation product, the Boomerang Catalyst™ System™, was launched in July 2007. This product uniquely provides the control to stop bleeding; allow for early patient ambulation (walking) as well leaving nothing behind in the patient; eliminating implant-related complications; and allowing for immediate re-access of the artery, if necessary.
At the end of the cath procedure, the Boomerang Catalyst wire is inserted into the artery through the existing arterial sheath used during the catheterization procedure. Once inside the artery, the Boomerang device opens into a bi-convex, low profile disc. Upon removal of arterial sheath, the Boomerang disc is positioned against the opening of the femoral artery, forming a temporary seal from inside of the vessel while applying site-specific compression. With the device in place, the arteriotomy relaxes back naturally around the Boomerang Wire. This natural elastic recoil of the arteriotomy is known as the “Boomerang Effect,” which returns the arteriotomy to its original puncture size (approximately an 18 gauge needle). When exposed, a proprietary coating on the wire disc further stimulates the body’s coagulation (blood clotting) response, which combined with the tight seal, accelerates clotting. After a short time the disc is deployed and then removed from the artery, leaving nothing behind.
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