News | June 01, 2009

U.S. Clinical Trial Slated for AXXESS Biolimus-Eluding Bifurcation Stent

June 1, 2009 - Devax Inc. today said FDA has conditionally approved an investigational device exemption (IDE) for its AXXESS Biolimus A9-Eluting Bifurcation Stent System, allowing the company to initiate a pivotal clinical trial (DIVERGE II) of the device in the U.S.

The DIVERGE II study is a multicenter, blinded, controlled, randomized trial comparing the treatment of bifurcation lesions with the AXXESS stent to standard techniques with conventional stents. The Principal Investigator is Jeffrey Moses, M.D., professor of medicine and director of the Center for Intravascular Therapy at Columbia University Medical Center in New York.

Bifurcation lesions occur in about 20 percent of patients treated for ischemic heart disease with coronary angioplasty and stenting. Recent large-scale clinical studies, such as SYNTAX and LEADERS, show lesions located at vessel bifurcations increase the frequency of major adverse cardiac events (MACE) by as much as 40 percent compared to lesions in straight vessel segments. Currently, there is no stent with an FDA approved indication for use in bifurcation lesions.

Devax has implanted more than 430 AXXESS stents in two clinical studies conducted outside the U.S. The second of these studies, DIVERGE I, enrolled 302 patients at 16 clinical centers in Europe, Australia, and New Zealand. The nine-month follow up for these patients was presented last October at the Transcatheter Therapeutics (TCT) conference in Washington, D.C. The data, published in the March 23, 2009 issue of the Journal of the American College of Cardiology, show high rates of clinical success and low rates of restenosis compared to other studies of bifurcations.

“DIVERGE II will be a landmark study because there are many novel aspects to the trial,” Dr. Moses said. “The AXXESS stent is the first drug-eluting stent dedicated solely to bifurcation lesions. We see these types of lesions frequently in daily practice, and they are difficult to treat with conventional stents and techniques. Also, this study is the first randomized study to compare a lesion-specific drug eluting stent to a standard device in a complex vessel anatomy.”

The Devax AXXESS technology is a proprietary self-expanding, nitinol stent specifically designed for the treatment of coronary and vascular bifurcation lesions. The conical shape of the stent is designed to conform to the bifurcation anatomy and provide full access to both branches for additional interventional procedures.

For more information:

Related Content

New FDA Proposed Rule Alters Informed Consent for Clinical Studies
News | Cardiovascular Clinical Studies | November 19, 2018
The U.S. Food and Drug Administration (FDA) is proposing to add an exception to informed consent requirements for...
A key slide from Elnabawi's presentation, showing cardiac CT plaque evaluations, showing the impact of psoriasis medication on coronary plaques at baseline and one year of treatment. It shows a reversal of vulnerable plaque development. #SCAI, #SCAI2018

A key slide from Elnabawi's presentation, showing cardiac CT plaque evaluations, showing the impact of psoriasis medication on coronary plaques at baseline and one year of treatment. It shows a reversal of vulnerable plaque development.  

Feature | Cardiovascular Clinical Studies | May 14, 2018
May 14, 2018 – New clinical evidance shows common therapy options for psoriasis (PSO), a chronic inflammatory skin di
Intravenous Drug Use is Causing Rise in Heart Valve Infections, Healthcare Costs. #SCAI, #SCAI2018
News | Cardiovascular Clinical Studies | May 14, 2018
May 14, 2018 — The opioid drug epidemic is impacting cardiology, with a new study finding the number of patients hosp
Patient Enrollment Completed in U.S. IDE Study of THERMOCOOL SMARTTOUCH SF Catheter
News | Cardiovascular Clinical Studies | March 15, 2018
March 15, 2018 –  Johnson & Johnson Medical Devices Companies announced today that Biosense Webster, Inc., who wo
Lexington Begins HeartSentry Clinical Trial
News | Cardiovascular Clinical Studies | February 20, 2018
February 20, 2018 – Lexington Biosciences, Inc., a development-stage medical device company, announced the commenceme
Endologix Completes Patient Enrollment in the ELEVATE IDE Clinical Study
News | Cardiovascular Clinical Studies | February 06, 2018
February 6, 2018 – Endologix, a developer and marketer of treatments for aortic disorders, announced the completion o
12-Month Results from Veryan Medical's MIMICS-2 IDE Study Presented at LINC
News | Cardiovascular Clinical Studies | February 01, 2018
February 1, 2018 – Thomas Zeller (Bad Krozingen, Germany) presented the 12-month results from Veryan Medical’s MIMICS
LimFlow Completes U.S. Feasibility Study Enrollment, Receives FDA Device Status
News | Cardiovascular Clinical Studies | February 01, 2018
February 1, 2018 –  LimFlow SA, developer of minimally-inv
ESC 2017 late breaking trial hot line study presentations.
News | Cardiovascular Clinical Studies | September 12, 2017
September 12, 2017 – The European Society of Cardiology (ESC) Congress 2017 includes several Hot Line Late-breaking C
U.K., NHS studies, weekend effect, hospital admission, atrial fibrillation, heart failure
News | Cardiovascular Clinical Studies | June 28, 2016
New research shows patients admitted to National Health Service (NHS) hospitals in the United Kingdom for atrial...
Overlay Init