Technology | July 09, 2012

r4 Vascular Announces Clearance of PTA Balloon

July 9, 2012 — r4 Vascular Inc. announced clearance from the U.S. Food and Drug Administration (FDA) to market the Vector percutaneous transluminal angioplasty (PTA) balloon catheters in 28 sizes. All Vector balloon catheter sizes are rated for up to 30 atmospheres of pressure and are radiopaque when deflated or inflated.

Vascular narrowings, lesions and blockages range from short and focal, to long and diffuse. Some lesions can be treated with basic low- pressure balloon catheters rated between 10 and 20 atmospheres, while other blockages may require advanced high-pressure balloons rated up to 30 atmospheres. High-pressure balloons are used to treat the full range of blockages, saving the physician and patient from the difficulties of initiating the procedure with a low-pressure balloon only to find out during the procedure that a high-pressure balloon is necessary.

High-pressure PTA balloons are used to keep hemodialysis access sites open for dialysis treatments, to restore blood flow in the legs, to dilate narrowings in renal (kidney) arteries and dilate lesions in other vessels throughout the body. The majority of PTA procedures are performed under X-ray fluoroscopic guidance.

r4’s patent pending Vector balloon catheter also includes radiopaque stripes on the balloon so physicians do not have to use viscous contrast media to visualize the balloon under X-ray. Instead, clinicians may use low-viscosity saline that reduces inflation/deflation time up to 50 percent and may reduce X-ray exposure to the patient and clinicians. Vector includes advanced catheter shaft technology to improve catheter tracking and handling.

For more information: www.r4vascular.com

Related Content

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...
Videos | Balloon Catheter | October 30, 2015
Todd Brinton, M.D., clinical associate professor and consulting associate professor of bioengineering at Stanford Uni
Overlay Init