FDA Clears North American Scientific’s ClearPath HDR Breast Brachytherapy System

North American Scientific Inc., a leading manufacturer of brachytherapy sources, announced that the Company has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) to market the high-dose rate radiation treatment design of ClearPath, its breast brachytherapy product designed to enhance current accelerated partial breast irradiation (APBI) treatment options.
"We believe that ClearPath's unique design will offer a new treatment alternative to women electing APBI as part of their Breast Conserving Therapy (BCT). The company's unique multichannel catheter system, which is inserted through a single incision, is designed to allow for either low-dose therapy, using the company's existing Prospera I-125 seeds, or high-dose rate treatments. Both of the ClearPath systems are designed to offer physicians greater flexibility in treatment planning and dose optimization to the target region while minimizing exposure to nearby healthy tissue," said L. Michael Cutrer, president & CEO of North American Scientific.
The ClearPath design really offers the best of both worlds when it comes to APBI treatment," said Dr. Rakesh Patel, professor of Radiation Oncology at the University of Wisconsin, who presented on the ClearPath device at ASTRO earlier this month along with Dr. David Schreiber of Littleton Radiation Oncology Center. "We have enjoyed collaborating with the team at North American Scientific and I look forward to treating patients with ClearPath since it offers an attractive alternative for physicians and patients seeking flexibility in breast cancer treatment," said Dr. Patel