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:4/28/2017)... ... ... Lowe is a popular actor that has been in many different movies and television ... host of the “Informed” series. The program focuses on many important issues that society ... thyroid cancer. , Although thyroid cancer is an uncommon type of cancer, people still ...
(Date:4/27/2017)... ... 2017 , ... The Incentive Research Foundation is pleased to ... a groundbreaking analysis of how behavioral economics can be applied to the incentive, ... programs, the report highlights proven behavioral economics approaches and the powerful role emotions ...
(Date:4/27/2017)... ... April 27, 2017 , ... ... North American CAREGiverSM of the Year for her extraordinary compassion and lifelong dedication ... 60,000 North American professional caregivers for the prestigious award each year – identifying ...
(Date:4/27/2017)... ... April 27, 2017 , ... Are you investing in the safety of your ... drownings during the summer. While most of us assume this type of accident will ... Very few people are taking the time to learn how to respond effectively or ...
(Date:4/26/2017)... ... April 26, 2017 , ... Journal of Oral Implantology ... have severe consequences to overall dental health, including complications with speech, eating, and overcompensation ... dental implants to replace lost teeth. As the number of tooth replacements increase, it ...
Breaking Medicine News(10 mins):
(Date:4/24/2017)... 24, 2017 Solentim, the developer of ... addition of a major new product line called ... The VIPS has been developed for automatically seeding ... as part of the process to generate clonally-derived ... and more reliable solution when compared to traditional ...
(Date:4/20/2017)... DUBLIN , April 20, 2017 ... the "Global Biosimilar Pipeline and Market Prospects: Addressing ... report to their offering. ... "Global Biosimilar Pipeline and Market ... by Design" provides an in-depth assessment of the current ...
(Date:4/20/2017)... AMSTERDAM , April 20, 2017  AbbVie ... that 99 percent (n=145/146) of chronic hepatitis C ... 4, 5 or 6 and compensated cirrhosis (Child-Pugh ... post-treatment (SVR 12 ) with its investigational, pan-genotypic ... rates were seen following 12 weeks of ...
Breaking Medicine Technology: