BIOTRONIK AG, a European manufacturer of therapy solutions for vascular intervention, has announced the international full market release of the innovative Pulsar-18 stent for treatment of long lesions in the superficial femoral and infrapopliteal arteries. Pulsar-18 is unique in the market, representing an advance in technology that further reinforces the company's position as a leader in providing high quality technologies for patients with peripheral vascular disease.
“The low profile, long lengths and innovative handle design demonstrate that BIOTRONIK deeply understands the complex nature of treating peripheral arterial disease, such as that found in the SFA, and is developing products that simplify interventions and optimize outcomes.”
The Pulsar-18 stent is the next generation of the market-leading Astron Pulsar stent and provides physicians with longer lengths of 100 mm up to 200 mm, optimized radial force and improved flexibility in diameters from 4 mm to 7 mm. The delivery system features an easy to use friction-reducing handle for smooth stent deployment, is compatible with a 0.018-in. guidewire and importantly, a 4F-sheath. The long stent lengths combined with the ultralow profile delivery catheter represent a much-anticipated technology advance.
Dr. Marc Bosiers, who is Head of the Department of Vascular Surgery at St. Blasius Hospital in Dendermonde, Belgium, and primary investigator of the 4EVER study, commented, "Studies comparing the results obtained with 4 F and 6 F catheters during coronary angiography via the femoral approach report fewer access complications, lower contrast use, decreased mortality and reduced hospitalization as the most important advantages of 4 F systems. Our experience confirms that the same advantages may be expected when using 4 F devices in peripheral arteries. Even with their small crossing profile, these 4 F devices offer the pushability needed for peripheral use."
"The Pulsar-18 is anticipated to be a flagship product for BIOTRONIK, and a highlight of our commitment to providing physicians with a full range of premium peripheral solutions that minimize access site complications," said VP of Sales and Marketing, Alain Aimonetti. "The low profile, long lengths and innovative handle design demonstrate that BIOTRONIK deeply understands the complex nature of treating peripheral arterial disease, such as that found in the SFA, and is developing products that simplify interventions and optimize outcomes."
The Pulsar-18 continues to be studied clinically in multiple trials, including the investigator-initiated 4EVER study, which is evaluating the efficacy of treating SFA lesions with Pulsar-18 and other 4 F-compatible products. The EXPAND study in Europe and Canada compares direct stenting with the Pulsar-18 to PTA with optional bail-out stenting for the treatment of below-the-knee (BTK) lesions.
The Pulsar-18 joins a full complement of BIOTRONIK peripheral devices that are 4 F-compatible, including the Passeo-18 PTA balloon, the Cruiser-18 guidewire and the Fortress 4 F reinforced introducer sheath.
Development of the Pulsar-18 into lengths from 20 mm to 80 mm is underway. Currently the Astron Pulsar stent, with its five years of proven safety and efficacy, addresses this clinical need.
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