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

The TIDES-ACS results show us that the Optimax stent is noninferior in patients with acute coronary syndrome compared to Synergy.

The presentation of the ESC late-breaker TIDES-ACS results show us that the Optimax stent is noninferior in patients with acute coronary syndrome compared to Synergy.

News | Stents| November 24, 2017
November 24, 2017 – During a late-breaking session at the European Society of Cardiology (ESC) 2017 meeting, presente
News | Stents| November 10, 2017
Cordis, a Cardinal Health company, recently unveiled a comprehensive interventional cardiology portfolio, which now...
OCT comparison between the Combo vs. Xience stents in the HARMONEE study.

OCT comparison between the Combo vs. Xience stents in the HARMONEE study.

Feature | Stents| November 08, 2017
November 8, 2017 – New results from the HARMONEE Japan/U.S.
FDA Approves COBRA REDUCE Trial of 14-Day DAPT With CeloNova Stent
News | Stents| October 27, 2017
CeloNova BioSciences Inc. announced the U.S. Food and Drug Administration (FDA) approved expansion of CeloNova's...
CeloNova Cobra Pzf stent
Technology | Stents| March 02, 2017
March 2, 2017 — The U.S. Food and Drug Administration (FDA) cleared CeloNova BioSciences Inc.
OCT, intravascular imaging, stent, good stent apposition on vessel wall, TRANSFORM-OCT study

An OCT image showing good stent strut apposition against the vessel wall.

News | Stents| January 13, 2017
January 13, 2017 — Results from TRANSFORM-OCT, a prospective, randomized trial using optical coherence tomography (OC
EXCEL Trial, TCT 2016, drug-eluting stents, CABG, surgery left main heart disease, LMCAD

Gregg W. Stone, M.D., presenting the EXCEL data at TCT 2016 during a standing room only late-breaking trial session.

Feature | Stents| January 12, 2017 | Dave Fornell
The biggest news from the 2016 Transcatheter Cardiovascular Therapeutics (TCT) meeting this past fall was the results
Biotronik's Osiro stent, prison IV trial

Biotronik's Osiro ultra-thin strut, sirolimus-eluting stent.

News | Stents| November 09, 2016
November 9, 2016 – Results from a randomized, multicenter trial failed to show non-inferiority of hybrid, ultra-thin
OCT stent strut coverage

OCT imaging showing neointimal tissue coverage of metallic stent struts.

News | Stents| November 07, 2016
November 7, 2016 – Results from TRANSFORM-OCT, a prospective, randomized trial using optical coherence tomography (OC
biosensors Biofreedom stent
News | Stents| November 07, 2016
November 7, 2016 – The two-year results from LEADERS FREE, the first randomized clinical trial dedicated to high blee
Overlay Init