Navigation Links
St. John Hospital 1st in Michigan to enroll patient in worldwide drug-coated balloon trial
Date:8/29/2011

Detroit Physicians at St. John Hospital and Medical Center have enrolled the first patient in Michigan in LEVANT2, a global, multicenter, randomized clinical trial evaluating the safety and effectiveness of the Moxy Drug Coated Balloon for the treatment of peripheral arterial disease. Thomas Davis, M.D., SJH&MC interventional cardiologist performed the case.

LEVANT 2, sponsored by medical device manufacturer Lutonix, Inc., is the first drug-coated balloon pivotal trial to be approved by the FDA. St. John Hospital is one of 55 centers around the world participating in the trial, which is expected to randomize 476 patients with diseased leg arteries. The trial will investigate whether the Moxy balloon is more effective than standard angioplasty at keeping leg arteries open and free from re-blockage over time.

LEVANT 2 is the largest randomized peripheral drug-coated balloon clinical trial to date, and one of the largest peripheral vascular studies ever conducted. Randomized patients in LEVANT 2 will be followed for a total of 5 years and independent core laboratories will be utilized to verify trial outcomes.

"We believe this trial may lead to a substantially better treatment option for patients with PAD," says Dr. Davis., LEVANT 2 site investigator at SJH&MC. "We are very proud of our ability to contribute to this important research and include ourselves in such a prestigious group of investigators around the world."

Drug-coated balloons are similar to standard angioplasty balloons except they are coated with an anti-restenosis drug aimed at preventing the artery from becoming blocked again. During the procedure, the Moxy balloon is inserted inside the narrowed area of the artery and then inflated in order to open the blockage and deliver the drug to the artery. After this short inflation, the balloon is removed from the body, leaving nothing but the drug behind in the artery.

"The potential opportunity to treat PAD without the use of a permanent implant is exciting. If the results of this trial are positive, we feel it could significantly change the way PAD is treated in the future," said Dr. Davis.

Restenosis refers to the re-narrowing of an artery following angioplasty or stenting. Restenosis is caused by an overgrowth of tissue inside the artery, typically in response to arterial injury at the original treatment site. Restenosis often occurs within the first 6 months following an intervention, and most often results in re-treatment.

LEVANT 2 is a follow-on trial to LEVANT 1, which was a 101-patient multicenter randomized trial. Patients either received the Moxy balloon or standard angioplasty for the treatment of diseased femoropopliteal arteries. Based on the success and positive results of the LEVANT 1 trial, LEVANT 2 was designed to investigate the device in a larger patient population.

"In trials of this magnitude and scientific rigor, it is imperative to have world-class research centers as your partners in the process. St. John Hospital is such an institution, and we are deeply appreciative of the commitment and resources they have dedicated to successfully enrolling this trial," said Dr. Dennis Wahr, CEO and co-founder of Lutonix.


'/>"/>

Contact: Brian Taylor
brian.taylor@stjohn.org
586-753-0726
St. John Providence Health System
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:6/26/2016)... ... June 26, 2016 , ... On June 10-11, 2016, A ... 2016 Cereal Festival and World’s Longest Breakfast Table in Battle Creek, MI, where the ... history as home to some of the world’s leading providers of cereal and other ...
(Date:6/25/2016)... , ... June 25, 2016 , ... ... policy issues and applications at AcademyHealth’s Annual Research Meeting June 26-28, 2016, at ... on several important health care topics including advance care planning, healthcare costs and ...
(Date:6/25/2016)... (PRWEB) , ... June 25, 2016 , ... As a ... Magna Cum Laude and his M.D from the David Geffen School of Medicine at ... returned to Los Angeles to complete his fellowship in hematology/oncology at the UCLA-Olive View-Cedars ...
(Date:6/24/2016)... ... ... Those who have experienced traumatic events may suffer from a complex set of ... or alcohol abuse, as a coping mechanism. To avoid this pain and suffering, Serenity ... event. , Trauma sufferers tend to feel a range of emotions, from depression, guilt, ...
(Date:6/24/2016)... ... June 24, 2016 , ... Dr. Amanda Cheng, an ... Cheng has extensive experience with all areas of orthodontics, including robotic Suresmile technology, ... , Micro-osteoperforation is a revolutionary adjunct to orthodontic treatment. It can be ...
Breaking Medicine News(10 mins):
(Date:6/24/2016)... June 24, 2016 Research ... "Structural Electronics 2015-2025: Applications, Technologies, Forecasts" ... In-Mold Electronics, Smart Skin, Structural Health ... Structural electronics involves electronic and/or electrical ... structures, replacing dumb structures such as vehicle bodies ...
(Date:6/24/2016)... Research and Markets has announced the addition of ... report to their offering. ... The World Market for Companion Diagnostics covers the world market ... the report includes the following: , World ... Region (N. America, EU, ROW), 2015-2020 , World IVD ...
(Date:6/24/2016)... , June 24, 2016  Arkis BioSciences, ... less invasive and more durable cerebrospinal fluid treatments, ... funding.  The Series-A funding is led by Innova ... Fund, and other private investors.  Arkis, new financing ... instrumentation and the market release of its in-licensed ...
Breaking Medicine Technology: