NuCryo Vascular Receives 510(k) Clearance for Next Generation Reusable Cryoplasty Inflation Device and Launches Direct Sales Model
SUNNYVALE, Calif.--(BUSINESS WIRE)--
NuCryo Vascular LLC today announced that they have received 510(k) clearance on the next generation reusable Cryoplasty Inflation Device and that NuCryo Vascular LLC will be selling the current and next generation model via a direct sales team.
The PolarCath Peripheral Dilatation System received FDA clearance to dilate stenosis in the peripheral vasculature (iliac, femoral, popliteal, infrapopliteal, renal, and subclavian arteries) and for the treatment of obstructive lesions of polytetrafluoroethylene (PTFE) access grafts or arteriovenous dialysis fistulae. The PolarCath System is also indicated for post-deployed stent expansion of self-expanding peripheral vascular stents. The PolarCath System was invented in Mountain View, CA by Dr. James Joye, an interventional cardiologist and a pioneer in developing medical devices to treat peripheral arterial disease.
The next generation PolarCath Peripheral Dilatation System consists of a disposable catheter, a reusable inflation unit, and a nitrous oxide cartridge. The system is used to perform balloon cryoplasty®, a catheter-based treatment that combines the inflation of a balloon with controlled cooling of the artery. The PolarCath System is used to dilate peripheral arteries with the same basic technique as balloon angioplasty, except that PolarCath uses nitrous oxide to inflate the balloon rather than liquid. The nitrous oxide cools the balloon to minus ten degrees Celsius, which freezes the built-up plaque in the artery.
“I am very excited with the FDA clearance of the next generation reusable Cryoplasty inflation device,” said Jack Casas, Interventional Cardiologist. “PolarCath, an FDA cleared device with over a decade of extensive clinical experience, is an important tool in the treatment algorithm for peripheral arterial disease. The reusable unit will substantially lower the PolarCath per case procedural cost and will allow PolarCath to be used more frequently in today’s cost conscience market.”
“The clearance of the next generation, reusable device is a huge milestone and highlights the engineering advancements we have made in the PolarCath system since reacquiring the rights back in 2014,” stated Dr. Joye. “Balloon cryoplasty has been shown in clinical studies and in everyday procedures to be an important option for treating peripheral arterial disease. The controlled cooling of the plaque and artery wall provides three potential benefits: uniform vessel dilation with less vessel trauma; reduced vessel wall recoil; and induction of apoptosis, promoting the natural cell death of the smooth muscle cells that otherwise proliferate to cause restenosis.”
The PolarCath system, which received its first FDA clearance in 2002, was developed by CryoVascular, Inc., a company formed by Dr. Joye and collaborators. In 2005, CryoVascular was acquired by Boston Scientific, which discontinued manufacturing PolarCath at the end of 2012. NuCryo Vascular was formed by Dr. Joye and several of the former CryoVascular executives and employees for the purpose of acquiring PolarCath and resuming manufacturing of the device. NuCryo Vascular has established a manufacturing facility for PolarCath in Sunnyvale, CA.
About NuCryo Vascular
NuCryo Vascular LLC is a privately held company that manufactures, markets, and sells the PolarCath (Cryoplasty) Balloon Dilatation System. NuCryo Vascular LLC is a subsidiary of Gemini Interventional Technologies, LLC. Gemini Interventional Technologies LLC is a privately held medical device start-up focused on developing, manufacturing, and marketing/selling novel devices to treat peripheral arterial disease (PAD).
For further information, connect to www.nucryovasc.com
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- Health Care Industry
- peripheral arterial disease
