Navigation Links
St. John Hospital enrolls first patient in US in trial of peripheral artery disease device
Date:9/13/2010

St. John Hospital and Medical Center in Detroit and Avinger, Inc., a medical device company focused on the development of innovative devices to combat peripheral artery disease, announced today 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 SJH&MC, who enrolled the first patient in the CONNECT trial and is one of the trial's co-principal investigators. "If we aren'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. In addition to Dr. Davis of SJH&MC, Dr. Laiq Raja of El Paso Cardiology Associates, P.A. and Providence Memorial Hospital in El Paso, Texas is a co-investigator.

"Avinger was created to develop technologies that change the way vascular disease is treated today," said Avinger CEO John B. Simpson, Ph.D., M.D. "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."


'/>"/>

Contact: Brian Taylor
brian.taylor@stjohn.org
586-753-0726
St. John Health
Source:Eurekalert

Related medicine news :

1. The private sale of drugs in public hospitals
2. Minnesota Department of Health Report: Nearly 6,000 Hospitalizations for COPD in 2007
3. Bariatricfurnishings.com Launches Unique Eco-friendly Seating for Health Care, Hospitality, Assisted Living Centers, and Home Use at Competitive Prices
4. Scott & White Memorial Hospital uses device to revolutionize treatment of traumatic aortic injury
5. Most pandemic plans in Ontario hospitals have not been tested: Queens University study
6. American Heart Association Comment on Hospitalization of President Bill Clinton
7. Allegheny General Hospital Study Demonstrates Safety and Potential Efficacy of Oral Allergy Treatment
8. SHARECOR Partners With Quantros, Inc. to Facilitate Core Measures and Regulatory Reporting in Louisiana Hospitals
9. Kaiser Foundation Health Plan and Hospitals Report Fourth Quarter and Fiscal Year 2009 Financial Results
10. Father Channels His Grief into Advocacy, Promotes Simple Actions to Make Hospitals Safer for Children
11. Catholic Health East and BayCare Health System Pledge $200,000 to Rebuild Hospital in Port-Au-Prince
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:10/13/2017)... ... October 13, 2017 , ... The Visiting Nurse Association (VNA) ... a collection of specialty vendors and unique items from across the nation, this holiday-themed ... and wellness services offered by the VNA. The boutique will be open Saturday, ...
(Date:10/13/2017)... Fairfax, VA (PRWEB) , ... October 13, 2017 ... ... provider of DevOps and Agile Software Development, has been awarded a contract by ... (EATS) Blanket Purchase Agreement (BPA) aims to accelerate the enterprise use of Agile ...
(Date:10/12/2017)... New Orleans, LA (PRWEB) , ... October 12, 2017 , ... ... fitness centers in the U.S., announced today its plans to open a flagship location ... club will occupy the former Rooms To Go store next to Office Depot in ...
(Date:10/12/2017)... (PRWEB) , ... October 12, 2017 , ... ... drug delivery system that we intend to develop to enable prevention of a ... lead to severe hearing loss, especially in pediatric patients. For cisplatin, hearing loss ...
(Date:10/12/2017)... ... October 12, 2017 , ... Women-owned and Grand ... Best and Brightest in Wellness® by Best and Brightest. OnSite Wellness will be ... Oct. 20 from 7:30 a.m. to 2 p.m. at the Henry Autograph Collection ...
Breaking Medicine News(10 mins):
(Date:9/23/2017)... Sept. 22, 2017 Janssen Biotech, Inc. (Janssen) ... letter from the U.S. Food and Drug Administration (FDA) ... sirukumab for the treatment of moderately to severely active ... clinical data are needed to further evaluate the safety ... active RA. ...
(Date:9/19/2017)... ANN ARBOR, Mich. , Sept. 19, 2017 HistoSonics, Inc., a venture-backed medical ... the precise destruction of targeted tissues, announced three leadership team developments today:   ... Josh Stopek, PhD ... ... Veteran medical device executive ...
(Date:9/18/2017)... , Sept. 18, 2017 EpiVax, ... of bioinformatics and immune engineering, today announced ... influenza A (H7N9) vaccine. ... to seasonal influenza and presents a challenge ... prior exposure to be effective. Using state-of-the-art ...
Breaking Medicine Technology: