August 8, 2018
NuCryo Vascular's PolarCath Peripheral Balloon Dilatation System to Be Distributed by Lokai Medical
August 9, 2018—NuCryo Vascular LLC announced that the company has signed a commercialization agreement with Lokai Medical to distribute the PolarCath balloon dilatation system in the United States. Lokai Medical is a specialty distributor of coronary/peripheral and interventional devices.
According to NuCryo Vascular, the PolarCath peripheral dilatation system received FDA clearance to dilate stenoses in the peripheral vasculature (iliac, femoral, popliteal, infrapopliteal, renal, and subclavian arteries) and for the treatment of obstructive lesions of polytetrafluoroethylene access grafts or arteriovenous dialysis fistulae. The PolarCath system is also indicated for postdeployed stent expansion of self-expanding peripheral vascular stents.
The company advised that the PolarCath cryoplasty system was invented by interventional cardiologist James Joye, MD, and developed by CryoVascular, Inc. In 2005, Cryovascular was acquired by Boston Scientific, which discontinued manufacturing PolarCath at the end of 2012. NuCryo Vascular was created in 2014 to acquire PolarCath and resume manufacturing the device. NuCryo Vascular has re-engineered the device and received FDA approval of the nonsterile inflation device in 2015.
In NuCryo Vascular's announcement, Jonathan Aliota, MD, commented, “I am very excited for the next-generation reusable Cryoplasty inflation device that NuCryo has re-engineered and brought back to market. As a previous Cryoplasty user with Boston Scientific, I recently reincorporated it back into my peripheral treatment algorithm and have been extremely happy with the results. In addition, the cost, ease of use, and time savings as compared to other balloons on the market have been well received at my facility.” Dr. Aliota is an interventional cardiologist in Houston, Texas.