Navigation Links
Devax Announces Completion of Enrollment of DIVERGE Trial of Novel Drug- Eluting Stent System for Bifurcation Lesions
Date:12/12/2007

- Five hundred patients treated with company's AXXESS(TM) System to date -

LAKE FOREST, Calif., Dec. 12 /PRNewswire/ -- Devax, Inc., a medical device company focused on developing next generation products for interventional cardiology, today announced that the Company has completed patient enrollment in the DIVERGE clinical trial evaluating its novel AXXESS(TM) Bifurcation Stent System. The DIVERGE trial, a prospective, multi-center trial which enrolled 302 patients, is the largest study conducted to date with a drug-eluting stent specifically designed for treating bifurcation lesions.

Bifurcation lesions are areas of atherosclerotic disease occurring at a location where one large vessel divides into two smaller vessels. A number of scientific papers estimate these lesions may occur in more than 500,000 people per year, or approximately 20 percent of all patients undergoing a stenting procedure worldwide.

"The DIVERGE trial and the AXXESS(TM) System are important because of the frequent presentation of bifurcation lesions in our daily clinical practice," said Stefan Verheye, M.D., Ph.D., co-principal investigator of the study and co-director of the Antwerp Cardiovascular Institute at the Middelheim Hospital in Antwerp, Belgium. "Conventional drug-eluting stents are technically challenging to place in bifurcation lesions since they are not designed for the unique anatomical characteristics of coronary bifurcations. As a result, these types of lesions are associated with high complication and restenosis rates compared to conventional lesions. We will submit the data for the next appropriate medical meeting."

To date, more than 500 patients worldwide have been treated using the AXXESS(TM) Bifurcation Stent System. More than 400 patients have received the drug-eluting version of the stent.

"The DIVERGE data will help guide our development and registration strategy to deliver to the market the first drug-eluting stent specifically designed for bifurcation lesions," said Paul Buckman, CEO of Devax. "We believe our customized approach will fulfill interventional cardiologists' desire to tailor care to the specific clinical needs of each patient."

About the Devax AXXESS(TM) Biolimus A9(R) Eluting Bifurcation Stent System

The Devax AXXESS(TM) Biolimus A9(R) Eluting Bifurcation Stent System is a proprietary self-expanding Nitinol stent specifically engineered for the treatment of coronary and vascular bifurcation lesions. The stent is coated with Biolimus A9(R), a drug uniquely formulated to prevent restenosis in a coronary artery and a next-generation bioabsorbable polymer, Polylactic acid (PLA), which is designed to release the drug over time. The conical shape of the stent is specifically designed to conform to the anatomy of the bifurcation and to provide interventional cardiologists with the ability to treat the bifurcation without compromising access to the side branch.

About Devax, Inc.

Devax, Inc. is a private, emerging medical device company developing a proprietary bifurcated stent system that is intended to provide a clinical solution to treat atherosclerotic disease in coronary bifurcations and left main coronary arteries. Coronary artery disease continues to be the number one cause of death in the United States and Europe. The Company believes there is significant potential for its unique stent system to serve as a platform technology to address and provide tailored care for bifurcations wherever they occur including those found in carotid and peripheral vascular disease. Devax is headquartered in Lake Forest, California.


'/>"/>
SOURCE Devax, Inc.
Copyright©2007 PR Newswire.
All rights reserved

Related medicine news :

1. HHS Announces $75 Million in Supplemental Funding to States for Pandemic Flu Preparedness
2. CRC Health Group Announces Acquisition of Bayside Marin Recovery Center, San Rafael
3. UHW Announces: Antelope Valley Hospital Caregivers and Board Vote to Ratify First Union Contract With SEIU UHW-West
4. HEI, Inc. Announces Sale of RFID Division Assets
5. Caraco Pharmaceutical Laboratories, Ltd. Announces FDA Approval to Market Generic Version of Zyloprim(R)
6. Mettler-Toledo International Inc. Announces Webcast of Presentation at Thomas Weisel Partners 2007 Healthcare Conference
7. Z Trim Announces Revocation of Gregory Halpern Severence Agreement
8. Brooke Franchise Corporation Announces Selected July Results
9. Manor Care, Inc. Announces Record Date for Special Stockholder Meeting
10. Caraco Pharmaceutical Laboratories, Ltd. Announces FDA Approval to Market Generic Version of Adipex-P(R)
11. Planet Technologies Announces Agreement to Acquire Antigen Laboratories
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:6/27/2016)... ... June 27, 2016 , ... A revolution is underway. ... ambulance transport experience for the millions of people who require these medical transport ... taxi industry through the use of technology. Now, SmartEMS has put forth an ...
(Date:6/26/2016)... ... June 26, 2016 , ... On June 10-11, 2016, A Forever Recovery, a ... and World’s Longest Breakfast Table in Battle Creek, MI, where the rehabilitation facility is ... to some of the world’s leading providers of cereal and other breakfast foods. Its ...
(Date:6/26/2016)... ... June 26, 2016 , ... Brent Kasmer, a legally blind and certified personal trainer is helping ... fitness app. The fitness app plans to fix the two major problems leading the fitness ... size fits all type program , They don’t eliminate all the reasons people ...
(Date:6/25/2016)... ... June 25, 2016 , ... Austin residents seeking Mohs surgery services, can ... Surgery and to Dr. Russell Peckham for medical and surgical dermatology. , Dr. Dorsey ... cancer. The selective fellowship in Mohs Micrographic Surgery completed by Dr. Dorsey was under ...
(Date:6/25/2016)... ... June 25, 2016 , ... First Choice Emergency Room , ... Sesan Ogunleye, as the Medical Director of its new Mesquite-Samuell Farm facility. , ... our new Mesquite location,” said Dr. James M. Muzzarelli, Executive Medical Director of First ...
Breaking Medicine News(10 mins):
(Date:6/24/2016)... June 24, 2016 According to ... Type (Standard Pen Needles, Safety Pen Needles), Needle Length ... Growth Hormone), Mode of Purchase (Retail, Non-Retail) - Trends ... report studies the market for the forecast period of ... USD 2.81 Billion by 2021 from USD 1.65 Billion ...
(Date:6/24/2016)... Tenn. , June 24, 2016  Arkis ... providing less invasive and more durable cerebrospinal fluid ... in funding.  The Series-A funding is led by ... Lighthouse Fund, and other private investors.  Arkis, new ... neurosurgical instrumentation and the market release of its ...
(Date:6/23/2016)... BEVERLY HILLS, Calif. , June 23, 2016 ... faced the many challenges of the current process. Many of ... option because of the technical difficulties and high laboratory costs ... would have to offer it at such a high cost ... to afford it. Dr. Parsa Zadeh , ...
Breaking Medicine Technology: