Medical Device Daily
The word boomerang typically brings to mind an image of a curved stick that, after you throw it, you better watch it fly since it may come around and conk you on the back of the head.
Thus, when naming its Boomerang Wire System, and, more recently, its Boomerang Catalyst System, Glenn Foy, president of Cardiva Medical (Mountain View, California) told Medical Device Daily that the company wanted to play up unique flexible characteristic of the device in facilitating vascular closure.
At the end of a percutaneous procedure, it allows the arteriotomy — a hole in the artery wall which began as a needle stick and has been dilated to accommodate the arterial sheath used during the catheterization procedure — to relax to its original diameter.
Cardiva this week reported launching its new Boomerang Catalyst System for vascular closure applications in such procedures. "It's actually a very fun name," Foy said.
Once the device is inserted into the artery though the existing arterial sheath used during the procedure, the Boomerang deploys a flat, low-profile disc. Upon removal of the sheath, the disc is positioned against the opening of the femoral artery forming a tight seal from inside the vessel.
A proprietary hemostatic coating on the spring-loaded section of the wire then stimulates the coagulation cascade which, combined with the tight seal, accelerates hemostasis, according to the company.
Foy said the "catalyst" part of the name is derived from the coating on the wire designed to stimulate coagulation.
After dwelling, the Boomerang disc is collapsed and completely removed from the artery, leaving nothing behind in the tissue tract or artery, Foy said. 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.
The product builds on the success of its predecessor, the Boomerang Wire System, which Cardiva says has been used to close femoral artery puncture sites in more than 70,000 percutaneous catheterization procedures since 2005. And it says that the Catalyst System is the first vascular closure device to achieve final hemostasis in the catheterization lab for diagnostic patients without leaving any foreign materials behind in the vessel, thereby eliminating a major cause of device failure and complication, the company said.
Approved for both diagnostic and interventional procedures, Cardiva first introduced the original Boomerang Wire System in May 2005.
During percutaneous catheterizations procedures, a catheter is threaded through the femoral artery to the site of vascular disease (usually 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, Foy told MDD: 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.
But there are considerable drawbacks to current approaches, he said. Specifically, manual management of the puncture site requires significant hospital resources, may require four to five hours of bed-rest, and may result in bleeding-related complications as well as vessel scarring. And while vascular closure devices achieve hemostasis in minutes, they have been associated with catastrophic complications and are not suitable for certain patients, Foy said.
The Boomerang technology is designed to address all of these shortcomings, according to Cardiva.
In a recent presentation at the EuroPCR meeting in Barcelona, in May, data presented showed that the Boomerang Catalyst System not only achieved final hemostasis in the cath lab for diagnostic patients, but also allowed interventional patients to get out of bed and walk hours sooner than manual compression patients, the company noted.
Leaving nothing in the tissue tract or artery, the Boomerang Catalyst System eliminates the primary source of implant-related complications that plague current vascular closure devices, Cardiva added. Additionally, immediate and future re-access to the vessel is preserved with the Catalyst System as scarring is mitigated compared to existing approaches.
The Boomerang Catalyst System also eliminates virtually all tissue tract blood oozing, which is a very common problem when implantable closure devices are used, according to the company.
"What we're excited about is that in some of our major centers across the U.S., many of our patients are repeat customers … It's very satisfying to us to hear the patients coming back who've had another method of closure, had a Boomerang, and are actually requesting it with their physicians," Foy said.
Along with the recent introduction of the Boomerang, Cardiva said it also launched its Pathway Program, a clinical education, training and outcomes monitoring program to help clinicians go beyond the discrete event of closure and deliver maximum near- and long-term benefit to patients, nurses and physicians in and out of the cath lab.
The new Boomerang Catalyst System, along with the supporting resources in Cardiva's Pathway Program, has received a positive response from cardiac centers and is quickly gaining acceptance by physicians across the U.S., the company says.
"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 early adoption of our product demonstrates that the Catalyst System delivers where other approaches fail, yielding unprecedented clinical safety and economic outcomes," said Augustine Lien, founder, CEO and chairman of Cardiva.
Cardiva's first product, the Boomerang Wire System, was approved in Europe and the U.S. in 2004 and brought to market in 2005. The second-generation product, the Boomerang Catalyst System, is approved in Europe and received FDA clearance in March.