The Spectranetics Corporation announced that it has submitted to the Food & Drug Administration (FDA) its Pre-Market Approval (PMA) application for the Stellarex drug-coated angioplasty balloon (DCB). Stellarex is designed to restore and maintain blood flow to the superficial femoral and popliteal arteries in patients with peripheral arterial disease (PAD).
“The Stellarex DCB has been studied extensively in two randomized controlled trials as part of the rigorous ILLUMENATE series that enrolled more than 1,100 patients,” said Amanda Johnson, Vice President of Regulatory and Medical Affairs. “Key opinion leaders have called the results reported to date ‘remarkable,’ especially in light of Stellarex’s low drug concentration. This PMA application marks a unique and important milestone in the future landscape of treating patients with PAD.”
President and CEO Scott Drake said, “Stellarex has been called a no-compromise solution with its low drug dosage and top-tier efficacy. The PMA application embodies our commitment to leading the way in clinical science by providing proven treatment algorithms backed by robust clinical evidence. We are preparing diligently for our launch into the United States market, which we anticipate in the second half of 2017, and are looking forward to improving patient care with this next-generation device.”
Spectranetics launched Stellarex in Europe in January 2015. Stellarex uses EnduraCoat™ technology, a durable, uniform coating designed to prevent drug loss during transit and facilitate controlled, efficient drug delivery to the treatment site. It is not for sale in the United States.
Stellarex enhances Spectranetics’ diversified suite of clinical solutions to treat complex cardiovascular conditions and expands its market opportunity in the projected USD 1 billion global DCB market.
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Dr. Reddy's Laboratories Ltd. is an integrated global pharmaceutical company, committed to providing affordable and innovative medicines for healthier lives. Through its three businesses - Pharmaceutical Services and Active Ingredients, Global Generics and Proprietary Products -Dr. Reddy's offers a portfolio of products and services including APIs, custom pharmaceutical services, generics, biosimilars. differentiated formulations and NCEs. Therapeutic focus is on gastro-intestinal, cardiovascular, diabetology, oncology, pain management, anti-infective and pediatrics. Major markets include India, USA, Russia and CIS, Germany, UK, Venezuela, S. Africa, Romania, and New Zealand.
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