Navigation Links
St. John Hospital enrolls first patient in US in trial of peripheral artery disease device

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
St. John Health

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. 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:
(Date:12/1/2015)... Wilmington, Delaware (PRWEB) , ... December 01, 2015 ... ... award winner at the 7th Annual 2015 Golden Bridge Business Awards under the ... is a zero capex web based sample management software that ...
(Date:12/1/2015)... (PRWEB) , ... December 01, 2015 , ... ... quantification and optimization of adjunctive imaging is the focus of numerous abstracts accepted ... meeting, November 29-December 4, 2015. Nine abstracts highlight the use of Volpara ...
(Date:12/1/2015)... ... December 01, 2015 , ... ... Excellence (BHCOE) today announced that the organization has awarded Education and Developmental Therapies ... a Distinguished Award. The award celebrates exceptional special needs providers that excel in ...
(Date:12/1/2015)... ... 2015 , ... TCS Healthcare Technologies (TCS), a leading provider ... is pleased to announce that VIP Care Services, a Caprock Health Group affiliate ... Complete Care™ Management to back their collaborative catastrophic case management initiatives. ACUITY Complete ...
(Date:12/1/2015)... ... ... With FCPX Overlay: Grit , users can apply a grit effect ... truly endless, all with a click of a mouse. Each user has full control ... of field and more, all within Final Cut Pro X. , With FCPX Overlay: ...
Breaking Medicine News(10 mins):
(Date:12/1/2015)... , 1 de diciembre de 2015 /PRNewswire/ ... para cuchillas de precisión, develó hoy un ... identidad de marca. El nuevo logo destaca ... y la ingeniería de productos con cuchillas ... ...
(Date:12/1/2015)... , Dec. 1, 2015 During ... in San Francisco, CA , ... to the coronary marketplace. During a satellite symposium, ... Stent Design to Minimize Restenosis", a renowned physician ... available Medinol NIRxcell™ CoCr Coronary Stent System and ...
(Date:12/1/2015)... 2015 Relmada Therapeutics, Inc. (OTCQB: RLMD), a clinical-stage ... announced today that the company will present at the LD ... at the Luxe Sunset Boulevard Hotel in Los ... Relmada Therapeutics, will present on Thursday, December 3, at 9:00 ... . Please register at least 10 minutes prior to the ...
Breaking Medicine Technology: