AccessClosure Launches new Vascular Closure Product

2011 is quickly shaping up to be the year of new product launches.

On the heels of Medtronic Inc.’s European rollout of its PEEK Prevail Cervical Interbody device and Arstasis Inc.’s U.S. debut of a femoral artery access product that allows cardiologists to perform an angiography without having to insert a vascular closure implant into a patient, comes the launch of AccessClosure Inc.’s Mynx Cadence Vascular Closure device (VCD).

Billed as a “next generation” device by the Mountain View, Calif.-based company, the Mynx Cadence VCD features a simpler design and improved ease-of-use by providing doctors a smoother deployment when they close the femoral artery.

“Designing enhanced solutions for vascular closure is our top priority and the design changes incorporated into the Mynx Cadence make it easier to use while maintaining the same feel our users have grown accustomed to,” Gregory D. Casciaro, AccessClosure’s president and CEO, said in a news release announcing the product launch. “We believe this device provides an excellent platform for growth as we continue to expand our user base.”

Three design changes on the new Mynx Cadence make it easier and more consistent to use, according to AccessClosure. For starters, the Mynx Cadence features a definitive shuttle stop, which reduces the possibility of over-shuttling when a doctor is administering the sealant. In addition, a single marker on the advancer tube gives doctors the data they need about sealant compression. And finally, a new sealant sleeve protects the sealant when it is administered and shortens the procedure time by eliminating the need to presoak during device preparation. These changes, the company claims, results in more consistent sealant delivery.

“My initial experience with the Mynx Cadence has been very positive,” said Elias Kassab, M.D., FACC, an interventional cardiologist from Oakwood Hospital in Detroit, Mich. “The design changes inspire increased confidence in the device, but I don’t feel that I’ve lost any of the tactile feedback I’m used to with the Mynx. These changes truly improve the experience of deploying the Mynx.”

The Mynx Vascular Closure Device utilizes a conformable, water‐soluble polyethylene glycol sealant to close the femoral artery. The sealant dissolves within 30 days, AccessClosure claims.

The Mynx received its first U.S. Food and Drug Administration approval in May 2007. Since then, it has been used in more than 700,000 procedures, and is available in two sizes for 5F and 6F/7F procedural sheaths.

Doctors can close the femoral artery after cardiovascular procedures in two ways—either by manual compression or with the help of vascular closure devices. Manual compression requires doctors to apply firm manual pressure directly to the access site for up to 30 minutes, a method that often is painful for the patient and forces them to be confined to bed in a hospital recovery room. Physicians frequently choose to use a VCD as an alternative to manual compression because it stops the bleeding more quickly and allows patients to be discharged sooner.

However, despite the benefits of VCDs, many patients find that deployment of a VCD is extremely painful. The Mynx addresses this drawback by eliminating the tugging and cinching of the artery that occurs with other closure devices. The sealant is designed for gentle placement on top of the artery without the use of a suture or permanent metal implant.

Founded in 2002, AccessClosure, Inc. is a privately held medical device company that develops access site management products for vascular closure procedures.