BIOTRONIK, a leading manufacturer of cardio- and endovascular medical devices, today announced the presentation of promising data from the iliac arm of the BIOFLEX-I clinical trial at the Cardiovascular Research Technologies (CRT) conference in Washington, DC. The BIOFLEX-I trial is designed to support Food and Drug Administration approval of the Astron self-expanding nitinol stent to treat patients suffering from common iliac or external iliac artery disease. National principal investigator for the study, Dr. Mark W. Burket, University of Toledo Medical Center, Ohio, presented results demonstrating that Astron had successfully met clinical endpoints for safety and efficacy.
For the iliac arm of the prospective, non-randomized, multi-center BIOFLEX-I trial, Astron stents were implanted in 161 patients at 34 centers in the US, Canada and Europe. The trial's primary endpoint was the composite rate of procedure or stent-related major adverse events (MAEs) at 12 months after implantation. MAEs were defined as 30-day mortality, clinically-driven target lesion revascularization (TLR) and limb amputation at 12 months. During the "Breakfast Symposium: Best Abstracts" at CRT, Dr. Burket announced that the 12-month composite endpoint of MAE was only 2.1% (p<0.001), well below the stent's performance goal, which was based on the trial results of similar self-expanding nitinol iliac stents.
"In this trial, Astron handily beat its pre-specified performance goal of 15% MAE at 12 months," stated Dr. Burket. "Astron has already proven itself as an excellent treatment option abroad in routine clinical practice for patients suffering from iliac artery disease. As the results of BIOFLEX-I show, Astron will be a helpful addition to the interventionalist's toolkit once approved for use in the US."
Dr. Burket reported that secondary outcomes were also positive. In the trial, Astron's 12-month primary patency rate was 89.8%, and the TLR rate was 1.4%. Additionally, patients demonstrated improvement in their ambulatory function and quality of life at 12 months compared to baseline, as evaluated by the walking impairment questionnaire score, a common screening tool for peripheral arterial disease.
"Astron has had CE mark since 2003 and is currently available in 45 countries. Astron stents have already improved quality of life for over 55,000 patients worldwide," commented Dr. Daniel Bühler, President, BIOTRONIK Vascular Intervention. "This track record of success, as well as the encouraging results of the BIOFLEX-I trial, emerge from our commitment to creating stents of the highest quality and safety."
More information on the BIOFLEX-I clinical study is available at www.clinicaltrials.gov, identifier: NCT01319812.
About Astron*
The Astron self-expanding nitinol stent system is designed to provide the specific performance characteristics required for iliac arteries. Astron features a peak-to-valley stent design with S-articulating connecting bars to provide multi-directional flexibility while avoiding fish-scaling in tortuous arteries. Furthermore, the segmented architecture and strut thickness are optimized to provide sufficient chronic outward force. Astron stents are coated with proBIO, a silicon carbide layer that reduces metal ion release from the stent surface into the surrounding tissue.
For the iliac arm of the prospective, non-randomized, multi-center BIOFLEX-I trial, Astron stents were implanted in 161 patients at 34 centers in the US, Canada and Europe. The trial's primary endpoint was the composite rate of procedure or stent-related major adverse events (MAEs) at 12 months after implantation. MAEs were defined as 30-day mortality, clinically-driven target lesion revascularization (TLR) and limb amputation at 12 months. During the "Breakfast Symposium: Best Abstracts" at CRT, Dr. Burket announced that the 12-month composite endpoint of MAE was only 2.1% (p<0.001), well below the stent's performance goal, which was based on the trial results of similar self-expanding nitinol iliac stents.
"In this trial, Astron handily beat its pre-specified performance goal of 15% MAE at 12 months," stated Dr. Burket. "Astron has already proven itself as an excellent treatment option abroad in routine clinical practice for patients suffering from iliac artery disease. As the results of BIOFLEX-I show, Astron will be a helpful addition to the interventionalist's toolkit once approved for use in the US."
Dr. Burket reported that secondary outcomes were also positive. In the trial, Astron's 12-month primary patency rate was 89.8%, and the TLR rate was 1.4%. Additionally, patients demonstrated improvement in their ambulatory function and quality of life at 12 months compared to baseline, as evaluated by the walking impairment questionnaire score, a common screening tool for peripheral arterial disease.
"Astron has had CE mark since 2003 and is currently available in 45 countries. Astron stents have already improved quality of life for over 55,000 patients worldwide," commented Dr. Daniel Bühler, President, BIOTRONIK Vascular Intervention. "This track record of success, as well as the encouraging results of the BIOFLEX-I trial, emerge from our commitment to creating stents of the highest quality and safety."
More information on the BIOFLEX-I clinical study is available at www.clinicaltrials.gov, identifier: NCT01319812.
About Astron*
The Astron self-expanding nitinol stent system is designed to provide the specific performance characteristics required for iliac arteries. Astron features a peak-to-valley stent design with S-articulating connecting bars to provide multi-directional flexibility while avoiding fish-scaling in tortuous arteries. Furthermore, the segmented architecture and strut thickness are optimized to provide sufficient chronic outward force. Astron stents are coated with proBIO, a silicon carbide layer that reduces metal ion release from the stent surface into the surrounding tissue.
