News | November 14, 2011

CryoPlasty Reduces Restenosis Rates by Nearly 50 Percent in Peripheral Stenting

November 14, 2011 – Boston Scientific welcomed positive outcomes from the COBRA clinical trial, which evaluated post-dilation of nitinol stents using CryoPlasty therapy with the PolarCath peripheral dilatation system compared to stenting with conventional balloon angioplasty in patients with diabetes presenting with blockages of the superficial femoral artery (SFA). The trial was funded through an unrestricted grant from Boston Scientific.

Results from the prospective, randomized, multi-center trial demonstrated a significant 47 percent relative reduction in binary restenosis rates for patients treated with nitinol self-expanding stents using post-dilation with the PolarCath System. The analysis was presented today during a late-breaking clinical trial session by principal investigator Subhash Banerjee, M.D., chief of the division of cardiology at VA North Texas Health Care and associate professor of medicine at the University of Texas Southwestern Medical School in Dallas, at the Cardiovascular Research Foundation's annual Transcatheter Cardiovascular Therapeutics (TCT) scientific symposium in San Francisco.

The COBRA trial enrolled 76 patients with 90 SFA lesions who were randomized to CryoPlasty therapy or conventional balloon angioplasty (CBA) for post-dilation of nitinol stents used to treat SFA blockages. Inclusion criteria included diabetes, severe claudication and SFA lesions requiring stents >5 mm in diameter and >60 mm in length. The primary endpoint is the rate of binary in-segment restenosis determined by duplex ultrasonography.

Follow-up data have been completed on 41 lesions in the CryoPlasty group and 43 lesions in the CBA group. Results at 12 months showed that binary restenosis was significantly lower in the CryoPlasty group (29.3 percent versus 55.8 percent, p=0.01). The secondary endpoint of change in the ankle-brachial index (ABI) from baseline to 12 months showed significant improvement in the CryoPlasty group (0.59+0.21 to 0.77+0.30, p=0.004) compared to the CBA group (0.62+0.19 to 0.65+0.26, p=0.66). ABI is the ratio of blood pressure in the lower legs to blood pressure in the arms, which can indicate the presence of blocked peripheral arteries (a higher number indicates less peripheral blockage). Procedural success was achieved in 100 percent of procedures in the CryoPlasty group.

"High restenosis rates remain a major limitation for peripheral stenting in treating patients with peripheral artery disease, particularly in patients with diabetes mellitus," said Banerjee. "Reducing revascularization rates is critical to improving outcomes, and these trial results show that CryoPlasty therapy can significantly reduce binary restenosis at least to 12 months in the studied patient population."

CryoPlasty therapy using the PolarCath peripheral dilatation system is a novel form of balloon angioplasty designed to treat atherosclerotic lesions in the peripheral arteries. This technology uses nitrous oxide in place of standard saline to fill an angioplasty balloon within a blocked artery, cooling the balloon's surface to minus 10 degrees Celsius. As the balloon is inflated, its surface cools and dilates the vascular lesion, potentially helping prevent artery re-blockage.

"CryoPlasty has become a useful treatment option for physicians whose patients are suffering from peripheral artery disease," said Jeff Mirviss, president of Boston Scientific's peripheral interventions business. "The COBRA trial results validate the use of CryoPlasty therapy for post-dilation of peripheral stents to modulate vessel response and potentially lower restenosis rates. Boston Scientific is committed to delivering innovative solutions and is pleased to be the only company to offer the CryoPlasty treatment option as part of our expanding peripheral portfolio."

The PolarCath peripheral dilatation system is approved in the United States for treating blockages in the peripheral vasculature and for post-dilation of self-expanding peripheral vascular stents.

For more information, visit,


Related Content

Transit Scientific announced the U.S. Food and Drug Administration (FDA) cleared the XO Score Percutaneous Transluminal Angioplasty (PTA) Scoring Sheath platform for use in iliac, ilio-femoral, popliteal, infra-popliteal and renal arterial plus synthetic and/or native arteriovenous hemodialysis fistula. This is a new type of scoring balloon technology.
News | Balloon Catheter | June 04, 2020
June 4, 2020 — Transit Scientific announced the U.S.
NC Trek RX Coronary Dilatation Catheter is part of an FDA Class I recall because it may not defalte.
News | Balloon Catheter | February 24, 2020
February 24, 2020 — Abbott has voluntarily recalled specific lots of two types of its coronary angioplasty catheters
Edwards Lifesciences Recalls IntraClude Intra-aortic Occlusion Device
News | Balloon Catheter | July 15, 2019
Edwards LifeSciences is recalling the IntraClude Intra-Aortic Occlusion Device due to a risk of balloon rupture during...
Gore Molding & Occlusion Balloon for Endovascular Aortic Repair Receives FDA Approval
Technology | Balloon Catheter | August 23, 2018
W. L. Gore & Associates Inc. (Gore) announced U.S. Food and Drug Administration (FDA) 510(k) clearance for the Gore...
Cardiovascular Systems Inc. and OrbusNeich Announce FDA Clearance  of Sapphire II Pro 1mm Coronary Balloon
Technology | Balloon Catheter | March 21, 2018
Cardiovascular Systems Inc. (CSI) recently announced that the U.S. Food and Drug Administration (FDA) has granted 510(k...
Cardiovascular Systems Expands Product Portfolio for Peripheral and Coronary Interventions
News | Balloon Catheter | January 24, 2018
Cardiovascular Systems Inc. recently announced two new partnerships broadening the company’s product portfolio. CSI is...
Abbott recalls its NC Balloon catheters
News | Balloon Catheter | May 22, 2017
May 22, 2017 — Abbott Vascular has initiated a voluntary recall of specific lots of three catheters due to 19 reports
Videos | Balloon Catheter | November 16, 2016
A discussion with Todd Brinton, M.D., about the newly FDA-cleared Shockwave Medical Lithoplasty System, at the Transc
NuCryo Vascular, Next Generation Cryoplasty Inflation Device, PolarCath Balloon Dilatation System

PolarCath Balloon Dilatation System image courtesy of NuCryo Vascular

Technology | Balloon Catheter | March 28, 2016
NuCryo Vascular LLC announced the launch of the Next Generation Cryoplasty Inflation device. The device received U.S....
NuCryo Vascular, FDA clearance, next-gen, PolarCath System, cryoplasty inflation device
Technology | Balloon Catheter | January 12, 2016
NuCryo Vascular LLC announced that they have received U.S. Food and Drug Administration (FDA) 510(k) clearance on the...