Navigation Links
First Patient Enrolled in 'CONNECT' Clinical Trial
Date:9/9/2010

REDWOOD CITY, Calif., Sept. 9 /PRNewswire/ -- Avinger, Inc., a medical device company focused on the development of innovative devices to combat peripheral artery disease, announces the enrollment of the first patient in the CONNECT (Chronic TOtal OcclusioN CrossiNg with thE WildCat CatheTer) clinical trial.  The CONNECT trial is a prospective, multi-center, non-randomized study intended to evaluate the Wildcat Catheter's ability to cross chronic total occlusions in femoropopliteal lesions.  Patients with peripheral artery disease may have chronic total occlusions which are sometimes difficult to treat with endovascular therapy resulting in either bypass surgery or amputation.  

The ability to cross chronic total occlusions (CTOs) enables subsequent endovascular treatment of peripheral artery disease and is directly related to acute procedural success and favorable long-term outcomes.  The Wildcat Catheter crosses CTO lesions by creating a small channel through the blockage using retractable spiral wedges creating a "corkscrew" effect enabling further treatment of the lesion with therapeutic devices.  The Wildcat Catheter received FDA 510(k) clearance in February 2009 for use as a guidewire support device to access discreet areas of the vasculature. Avinger is conducting this study to secure FDA clearance for an indication specific to crossing CTOs.

"We are very excited by this new technology," said Dr. Thomas Davis of St. John Hospital and Medical Center, who enrolled the first patient in the CONNECT trial. "If we weren't able to cross this CTO with the Wildcat, the only other option for this patient would have been a surgical bypass or amputation.  With the help of this technology we will hopefully be able to change the paradigm of treatment from surgical to endovascular."

The CONNECT study will evaluate 88 PAD patients with femoropopliteal CTO lesions at 15 centers in the US.  Patients will be followed for 30 days post procedure and an independent group of physicians will review the angiography results to determine crossing efficacy and safety.  Conditional FDA approval to conduct this study was received on August 11, 2010.  Co-Principal investigators for the trial are Dr. Thomas Davis of St. John Hospital and Medical Center in Detroit, Michigan and Dr. Laiq Raja of El Paso Cardiology Associates, P.A. and Providence Memorial Hospital in El Paso, Texas.

"Avinger was created to develop technologies that change the way vascular disease is treated today," said Avinger CEO John B. Simpson, PhD, MD.  "The CONNECT trial will provide clinical data to help guide physicians in the use of the Wildcat and provide expanded treatment options for PAD.  We hope that Avinger can play a key role in helping patients facing an amputation keep their leg."

About AvingerFounded in 2007 by John B. Simpson, PhD, MD, Avinger, Inc. (http://www.avinger.com) is developing the next generation of catheter-based technologies for the treatment of cardiovascular and peripheral vascular disease utilizing our core competencies in medical device catheter engineering and intravascular imaging. Avinger Contact John D. Simpson Vice President, Commercial Operations Phone: +1 650 363 2400 jd@avinger.com
'/>"/>

SOURCE Avinger, Inc.
Copyright©2010 PR Newswire.
All rights reserved

Related medicine technology :

1. Reclast(R) Receives US FDA Approval as First and Only Once-Yearly Treatment for Women With Postmenopausal Osteoporosis
2. Sixty-One Percent of Newly Diagnosed Parkinsons Disease Patients Do Not Receive Any Drug Treatment in the First Year of Diagnosis
3. Xenomics Announces Implementation of its First Diagnostic Test for Acute Myeloid Leukemia Into Clinical Practice
4. GlaxoSmithKline Receives New HHS Order for H5N1 Bulk Antigen. First North American Clinical Trials with GSKs Candidate Pre-pandemic Flu Vaccine to Start.
5. Video: Landmark Study in The Lancet: Patients Treated With Betaseron(R) After First MS Attack Experienced Significant Delay in MS Progression
6. Peregrine Pharmaceuticals Doses First Patient in Cotara(R) Phase II Brain Cancer Trial In India
7. Tainted Chinese Food Ingredients First Discovered in 2005
8. First Patient Enrolled in Europe in Ovature Phase III Ovarian Cancer Trial
9. Protalix BioTherapeutics Treats First Patient in Phase III Clinical Trial of prGCD
10. Human Genome Sciences Completes Enrollment of First Phase 3 Albuferon(R) Trial Ahead of Schedule
11. Opko Health Doses First Patient in Phase 3 COBALT Trial of Bevasiranib for the Treatment of AMD
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:6/20/2017)... HILLS, Calif. , June 20, 2017 SkylineDx ... the use of MMprofiler with SKY92, the company,s prognostic ... In a poster presentation at the 22 nd ... Madrid, Spain , SkylineDx researchers will demonstrate ... patients. In a separate e-poster presentation ...
(Date:6/16/2017)... 2017  Exactly 50 years ago today, the Monterey Pop ... known as the San Francisco "Summer of Love."  To celebrate ... radical innovations in strategic market research portals that it will ... beginning of Northern Light,s "Summer of Love (For Our Customers)."  ... ...
(Date:6/13/2017)... , June 13, 2017 Zimmer Biomet Holdings, ... healthcare, today announced that the U.S. Food and Drug Administration ... June 3, 2015 relating to its Zhejiang, China ... "The successful clearance of the Warning ... manufacturing facility is a measure of the progress we ...
Breaking Medicine Technology:
(Date:6/28/2017)... ... June 28, 2017 , ... The Wharton School’s Aresty Institute ... as a kick-off to the fifth annual CEO Connection Mid-Market Convention. , ... of Pennsylvania campus, followed by the two-day convention, which will target C-suite executives ...
(Date:6/28/2017)... Santa Clara, CA (PRWEB) , ... June 28, 2017 , ... ... is hosting a free AFM Luncheon for all SEMICONWest attendees and Park ... The luncheon will feature talks from Dr. Sang-il Park, Chairman & CEO of Park ...
(Date:6/28/2017)... ... June 28, 2017 , ... Schneider ... planning assistance to clients in southern Montana, is announcing a focused charity effort ... , The outreach programs offered by Zoo Montana provide students with current knowledge ...
(Date:6/28/2017)... ... June 28, 2017 , ... Designers Insurance Agency, a ... northern Virginia and DC, is announcing a cooperative charity event in conjunction with ... other disorders that lead to memory impairment. , The Insight Memory Care Center ...
(Date:6/27/2017)... , ... June 27, 2017 , ... ... the appointment of Mike Finnegan to the position of Executive Vice President, Sales ... experience in healthcare technology, telehealth and medical device sales leadership. He has received ...
Breaking Medicine News(10 mins):