LAKE OSWEGO, OR, USA, October 8, 2013 – BIOTRONIK, a leading manufacturer of cardiovascular technology, announced today that it has completed patient enrollment in the iliac arm of its BIOFLEX-I trial. Under the supervision of national primary investigator Dr. Mark W. Burket, Chief of the Cardiovascular Division at the University of Toledo Medical Center in Toledo OH, the trial will evaluate the safety and effectiveness of the Astron and Pulsar-18 stents in the treatment of peripheral vascular disease with a view towards gaining FDA approval.
The BIOFLEX-I trial is a prospective, non-randomized, multi-center IDE study consisting of two arms: SFA (superficial femoral artery) and iliac. Alongside ongoing enrollment in the SFA arm, the newly completed iliac arm evaluates the use of the Astron stent in the treatment of common or external iliac artery lesions. Astron is CE-marked and commercially available in over 50 countries worldwide. Astron stents were successfully implanted in 160 patients at 34 centers in the U.S. and Europe, completing enrollment in the iliac arm of the BIOFLEX-I trial.
“When treating disease in the iliac arteries, it’s important to have a variety of tools at your disposal,” commented Dr. Burket. “The Astron stent is an excellent option in the self-expanding category. Its flexibility, ease of deployment, and passive PROBIO coating make it a suitable choice for many patients.”
“The completion of enrollment in the iliac arm of this study represents an important milestone in BIOTRONIK’s goal to deliver our innovative peripheral intervention products to US physicians,” explained Dr. Daniel Bühler, President Vascular Intervention, BIOTRONIK. “We look forward to positive results from this portion of BIOFLEX-I, and feel sure that we will ultimately be able to provide physicians with further proven treatment options for cardiovascular disease.”
More information on the BIOFLEX-I clinical study is available at www.clinicaltrials.gov identifier: NCT01319812.
About BIOTRONIK SE & Co. KG
As one of the world’s leading manufacturers of cardiovascular medical devices, BIOTRONIK is headquartered in Berlin, Germany, and represented in over 100 countries by its global workforce of more than 5,600 employees. Several million heart patients around the world have received BIOTRONIK implants, designed to save and improve the quality of their lives. Since its development of the first German pacemaker in 1963, BIOTRONIK has launched several innovations into the market—including remote monitoring with BIOTRONIK Home Monitoring® in 2000 and the world’s first implantable cardioverter-defibrillators and implantable heart failure therapy devices with ProMRI® technology, approved for MR scanning, in 2012. This year BIOTRONIK is celebrating its 50th anniversary.
For more information, visit: www.biotronik.com
1 Dick et al. Catheterization and Cardiovascular Interventions 74:1090–1095 (2009)
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