News | June 12, 2009

Cook Completes Patient Enrollment in REFORM Clinical Trial

June 11, 2009 - Cook Medical announced today the completion of patient enrollment in its REFORM clinical trial, designed to evaluate Cook’s advanced Formula Balloon Expandable Stent for the treatment of renal artery stenosis.

The trial, designed to evaluate the safety and effectiveness of the Formula Balloon Expandable Stent for the treatment of renal artery atherosclerosis against well-established performance data, enrolled 100 patients at seven investigative sites throughout the U.S. Initial clinical results on the trial’s endpoint of revascularization of the target lesion to perfuse the kidney measured at nine months post-procedure are expected to be available in Q2 of 2010, and an FDA regulatory submission is expected to be made based on those data.

The extremely low profile of the Formula Balloon Expandable Stent is lower than many cobalt chromium stent platforms. In addition, the stent does not shorten upon expansion, which can potentially improve accurate placement across the diseased lesion.

The Formula Balloon Expandable Stent is an investigational device and is not currently approved for treatment of renal artery stenosis in the United States.

For more information: www.cookmedical.com

Related Content

First European Patient Enrolled in Intact Vascular's TOBA II BTK Trial
News | Stents Peripheral| July 26, 2017
Intact Vascular Inc. recently announced that its Tack Optimized Balloon Angioplasty II Below the Knee (TOBA II BTK)...
First Patient Treated in U.S. Feasibility Study of LimFlow Critical Limb Ischemia Device
News | Peripheral Artery Disease (PAD)| July 17, 2017
LimFlow SA announced enrollment of the first patient in the U.S. feasibility study of the LimFlow Percutaneous Deep...
FDA Approves Six-Month Primary Endpoint for Tack Endovascular System in Below the Knee Disease
News | Stents Peripheral| July 14, 2017
Intact Vascular Inc. announced the U.S. Food and Drug Administration (FDA) approved an Investigational Device Exemption...
Onyx DES 2.0 mm stent meets primary endpoints in small vessels
News | June 12, 2017
June 12, 2017 – The Medtronic Resolute Onyx Drug-Eluting Stent (DES) met its primary endpoint of target lesion failur
First Pennsylvania Patient Treated in LEADERS FREE II Trial of BioFreedom Drug-Coated Stent
News | Stents Drug Eluting| May 12, 2017
PinnacleHealth CardioVascular Institute enrolled the first patient in Pennsylvania in a trial assessing the safety and...
Resolute Onyx DES, drug eluting stent, medtronic, gains FDA approval
Technology | Stents Drug Eluting| May 01, 2017
May 1, 2017 — The U.S.
Sponsored Content | Videos | Stents Drug Eluting| May 01, 2017
This video, provided by Medtronic, demonstrates the Resolute Onyx coronary stent.
New Twelve-Month Data Show Efficacy of Pulsar-18 Bare Metal Stent
News | Stents Peripheral| April 28, 2017
Biotronik’s Pulsar-18 bare metal stent (BMS) has yielded high primary patency in a real-world setting, according to the...
Tryton Medical, Side Branch Stent, first U.S. commercial case, New York-Presbyterian Hospital, Columbia University Medical Center
News | Stents Bifurcation| March 31, 2017
Tryton Medical Inc. recently announced that the first U.S. commercial case using the Tryton Side Branch Stent was...
Sponsored Content | Videos | Stents Bioresorbable| March 30, 2017
Stephen Ellis, M.D., professor of medicine and director of interventional cardiology at Cleveland Clinic, discusses t
Overlay Init