BIOTRONIK Announces First Enrollments to BIOFLEX PEACE Registry
Study to Observe Pulsar-18 Stent Performance in Up to 500 Patients with Extensive Subgroup Analyses with 24 Month Follow-Up
BUELACH, Switzerland, July 10, 2014 – BIOTRONIK, a leading manufacturer of cardio- and endovascular devices, has announced the start of enrollment and first Pulsar-18 stent implantations in the investigator-initiated BIOFLEX PEACE study. Building on positive results for the 4F stent in the earlier 4EVER and PEACE trials, this new all-comers registry is designed to evaluate the Pulsar-18’s efficacy for interventions on femoropopliteal lesions in a larger group of patients in a real-world setting.
The BIOFLEX PEACE all-comers registry is a prospective, single-arm, multicenter study, which will investigate the treatment of femoropopliteal atherosclerotic lesions, following patients out to 24 months. Primary endpoints are major adverse events (MAE) at six months and primary patency at 12 months. Secondary endpoints include clinical success (defined as improvement by one or more Rutherford class), target lesion revascularization (TLR), amputation rate, along with improvement in pain rating score and walking impairment. Extensive subgroup analyses are planned, including lesion location, lesion preparation prior to stenting, and stent oversizing.
“Following up on the successful PEACE I study, which reported a primary patency rate of 79.5 percent and a freedom from TLR rate of 81.0 percent, BIOFLEX PEACE will enroll up to 500 patients to evaluate the safety and efficacy of Pulsar stents in a real-world setting,” commented lead investigator Dr. Michael Lichtenberg of the Vascular Center Clinic in Arnsberg, Germany. “This extensive cohort will allow subgroup analyses of different treatment strategies—including lesion preparation, the importance of correct stent sizing and spot stenting, amongst others —with the goal of assessing the efficacy of these respective approaches.”
“We are very keen to see how the Pulsar stent performs in the variously confined subgroups,” stated Dr. Alexander Uhl, BIOTRONIK Vice President Marketing, Vascular Intervention.
“Due to its innovative design, the Pulsar stent has so far consistently demonstrated favorable patency as compared to thick strut stents, but with the additional advantage of lower profile, lower wound complication rates, reduced procedure cost and faster ambulation time. We look forward to the data regarding our Pulsar stent’s performance in a much wider cohort of patients, which should further confirm the benefits of a ‘low-profile’ approach for lower limb interventions.”
Pulsar stents feature an innovative, highly flexible design coated with proBIO, a silicon carbide layer that improves the stent's hemocompatibility and biocompatibility, which is believed to contribute to its excellent clinical results. Pulsar-18 is available in diameters of 4 to 7 mm and lengths of 20 to 200 mm, all deliverable through a 4F sheath.
One of the world’s leading manufacturers of cardio- and endovascular 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 patients have received BIOTRONIK implants designed to save and improve the quality of their lives, or have been treated with BIOTRONIK coronary and peripheral vascular intervention products. Since its development of the first German pacemaker in 1963, BIOTRONIK has engineered many innovations, including BIOTRONIK Home Monitoring®; the world’s first 4F-compatible 200mm peripheral stent; Orsiro, the industry’s first hybrid drug-eluting stent; and the world’s first implantable cardioverter-defibrillators and heart failure therapy devices with ProMRI® technology.
For more information, visit: www.biotronik.com
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BIOTRONIK SE & Co. KG
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