News | August 08, 2014

Biotronik Announces Completion of Enrollment in SFA Arm of the BIOFLEX-I Study

Biotronik Enrollment Completion SFA Arm BIOFLEX-I Study Pulsar-18 4-French

August 8, 2014 — Biotronik announced the completion of patient enrollment in the superficial femoral artery (SFA) arm of its BIOFLEX-I clinical trial, an U.S. Food and Drug Administration (FDA)-approved investigative device exemption (IDE) trial evaluating the use of self-expanding nitinol stents in treating peripheral artery disease (PAD). A total of 296 patients were successfully implanted with the Astron Pulsar and Pulsar-18 stents at 34 centers in the United States, Canada and Europe.

The investigational Pulsar-18 is currently the only self-expanding stent with 4-French introducer sheath compatibility for stent diameters of up to 7 mm and lengths of up to 200 mm. It represents a major advance in the minimally invasive treatment of lower limb disease. Pulsar-18 is designed to have high bending and axial flexibility. Its sufficient chronic outward force and crush resistance are intended to support the vessel while minimizing the risk of inflammatory response that can be triggered by excessive chronic outward force.

“The ability to deliver an SFA stent through a 4-French sheath expands the possibilities for patient treatment,” commented Carlos Mena, Yale New Haven Hospital, New Haven, Conn. Mena is the first U.S. physician to implant a Pulsar-18 stent through a 4-French sheath. “The flexible Pulsar-18 has a low crossing profile that is advantageous, allowing use not only through the 4-French sheath, but also in tight lesions of the SFA.”

Pulsar-18 and 4 French approaches to lower limb interventions were validated in several independent studies, including the 4EVER study, which showed excellent technical success, safety and efficacy for up to two years. In this study, the primary patency of Pulsar-18 was 73.4 percent at 12 months and 69.7 percent at 24 months.1 More recently, the Pulsar-18 stent showed 79.5 percent primary patency 12-month results in the PEACE I all-comers registry. [2]

“Achieving this enrollment goal in the BIOFLEX-I study brings us one step closer to having these novel products available to US physicians for the treatment of lower limb disease,” remarked principal investigator Mark W. Burket, University of Toledo Medical Center, Toledo, Ohio. “The Pulsar-18 and Astron stents will give physicians greater opportunity to treat peripheral vascular disease, thereby improving patient quality of life.”

For more: www.biotronik.com, www.clinicaltrials.gov

References:

1.Bosiers M, et al. Journal of Endovascular Therapy. 2013, 20(6)

2.Lichtenberg M, et al. Journal of Endovascular Therapy. 2014, 21(3)

Related Content

A key slide from Elnabawi's presentation, showing cardiac CT plaque evaluations, showing the impact of psoriasis medication on coronary plaques at baseline and one year of treatment. It shows a reversal of vulnerable plaque development. #SCAI, #SCAI2018

A key slide from Elnabawi's presentation, showing cardiac CT plaque evaluations, showing the impact of psoriasis medication on coronary plaques at baseline and one year of treatment. It shows a reversal of vulnerable plaque development.  

Feature | Cardiovascular Clinical Studies | May 14, 2018
May 14, 2018 – New clinical evidance shows common therapy options for psoriasis (PSO), a chronic inflammatory skin di
Intravenous Drug Use is Causing Rise in Heart Valve Infections, Healthcare Costs. #SCAI, #SCAI2018
News | Cardiovascular Clinical Studies | May 14, 2018
May 14, 2018 — The opioid drug epidemic is impacting cardiology, with a new study finding the number of patients hosp
Patient Enrollment Completed in U.S. IDE Study of THERMOCOOL SMARTTOUCH SF Catheter
News | Cardiovascular Clinical Studies | March 15, 2018
March 15, 2018 –  Johnson & Johnson Medical Devices Companies announced today that Biosense Webster, Inc., who wo
Lexington Begins HeartSentry Clinical Trial
News | Cardiovascular Clinical Studies | February 20, 2018
February 20, 2018 – Lexington Biosciences, Inc., a development-stage medical device company, announced the commenceme
Endologix Completes Patient Enrollment in the ELEVATE IDE Clinical Study
News | Cardiovascular Clinical Studies | February 06, 2018
February 6, 2018 – Endologix, a developer and marketer of treatments for aortic disorders, announced the completion o
12-Month Results from Veryan Medical's MIMICS-2 IDE Study Presented at LINC
News | Cardiovascular Clinical Studies | February 01, 2018
February 1, 2018 – Thomas Zeller (Bad Krozingen, Germany) presented the 12-month results from Veryan Medical’s MIMICS
LimFlow Completes U.S. Feasibility Study Enrollment, Receives FDA Device Status
News | Cardiovascular Clinical Studies | February 01, 2018
February 1, 2018 –  LimFlow SA, developer of minimally-inv
ESC 2017 late breaking trial hot line study presentations.
News | Cardiovascular Clinical Studies | September 12, 2017
September 12, 2017 – The European Society of Cardiology (ESC) Congress 2017 includes several Hot Line Late-breaking C
U.K., NHS studies, weekend effect, hospital admission, atrial fibrillation, heart failure
News | Cardiovascular Clinical Studies | June 28, 2016
New research shows patients admitted to National Health Service (NHS) hospitals in the United Kingdom for atrial...
stroke risk
News | Cardiovascular Clinical Studies | August 28, 2015
Most people assume strokes only happen to octogenarians, but recent evidence suggests that survivors of childhood can
Overlay Init