FDA grants Pathway marketing clearance for JETSTREAM Navitus revascularization catheter for PVD

Jun 6 2011

Pathway Medical Technologies, Inc, an innovator of endovascular treatments for peripheral vascular disease (PVD), announced today that the U.S. Food and Drug Administration (FDA) has granted the company 510(k) clearance to market JETSTREAM Navitus^TM, an enhanced revascularization catheter for the treatment of PVD. Offering greater flexibility, unsurpassed cutting effectiveness and improved guidewire performance, JETSTREAM Navitus is a highly effective option for treating calcium blockages and chronic total occlusions (CTOs) in the PVD patient population. JETSTREAM Navitus is now available for sale throughout the United States.

“The power, flexibility and effectiveness of Navitus underscore Pathway's position as the leading innovator of PVD technology. We look forward to continuing to lead the market with cutting-edge products that are quickly gaining acceptance from leading physicians across the country.”

"The JETSTREAM Navitus offers interventionalists an evolutionary new tool to treat the most calcified lesions in the infra-inguinal vascular space," says Andrey Espinoza, M.D., FACC, FSCAI, medical director at Hunterdon Medical Center in New Jersey. "The design iterations provide a superior cutting platform with enhanced flexibility and an excellent deliverability profile. The JETSTREAM Navitus will allow a wider spectrum of patients to benefit from this generational technology."

"Navitus demonstrates our commitment to providing physicians with the best minimally invasive tools for treating the more than 12 million people in the U.S. who suffer from peripheral artery disease," said Pathway Medical Technologies President and CEO Paul Buckman. "The power, flexibility and effectiveness of Navitus underscore Pathway's position as the leading innovator of PVD technology. We look forward to continuing to lead the market with cutting-edge products that are quickly gaining acceptance from leading physicians across the country."

New features and benefits of JETSTREAM Navitus include:

• Improved Performance in Tortuous Anatomy—Enhanced drive line design provides for coaxial guidewire movement through the length of the catheter, offering enhanced flexibility, reduced friction and smooth movement through the curves of the peripheral vasculature.
• Highly Effective Therapy for Calcium and CTOs—Navitus provides front-end cutting and unsurpassed differential cutting effectiveness that make it ideal for treating even the most difficult and substantial blockages.
• Active Aspiration—The JETSTREAM family of products remain the only atherectomy devices on the market to offer active aspiration. This feature allows the operator to continually aspirate (remove) excised tissue and thrombus while the device is operating. Unlike other competitive products that require users to stop treatment and empty collection chambers or simply deposit debris in the arterial beds downstream, JETSTREAM's active aspiration is an important safety feature that both reduces procedure time and minimizes the risk of distal embolization.
• Single Device Solution—Navitus features expandable blade technology that enables treatment of blockages from the superficial femoral artery to below the knee, empowering physicians to treat all lesion morphologies.