The Spectranetics Corporation (NASDAQ:SPNC) announced today 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 $1 billion global DCB market.
About the ILLUMENATE Clinical Program
There are five ILLUMENATE clinical studies evaluating the safety and efficacy of the Stellarex DCB platform and support United States and Canadian regulatory filings.
|•||The ILLUMENATE First-In-Human (FIH) Study was a non-randomized, multi-center study that enrolled 80 patients. In the pre-dilatation arm (n=50), the primary patency rate at was 89.5% at 12 months and 80.3% at 24 months.|
|•||The ILLUMENATE Pharmacokinetic Study measured the Paclitaxel drug levels in the blood of 25 patients enrolled at two sites.|
|•||The ILLUMENATE EU Randomized Trial is a prospective, randomized controlled, multi-center trial with 328 patients enrolled at 18 sites. The primary safety and effectiveness endpoints were met and superiority over PTA was demonstrated in both. The 12-month primary patency rate was 89.0% vs. 65.0% in the PTA arm (p<0.001).|
|•||The ILLUMENATE Global study is a prospective, multi-center, single-arm study with 371 patients enrolled. Interim data on the first 220 subjects showed a primary patency rate of 86.5% at 12 months.|
|•||The ILLUMENATE Pivotal Study is a prospective, randomized controlled, multi-center trial with 300 patients enrolled at 43 sites to support U.S. FDA approval.|
The Spectranetics Corporation develops, manufactures, markets and distributes medical devices used in minimally invasive procedures within the cardiovascular system. The Company’s products are available in over 65 countries and are used to treat arterial blockages in the heart and legs and in the removal of pacemaker and defibrillator leads.
The Company’s Vascular Intervention (VI) products include a range of laser catheters for ablation of blockages in arteries above and below the knee, the AngioSculpt scoring balloon used in both peripheral and coronary procedures, and the Stellarex drug-coated balloon peripheral angioplasty platform, which received European CE mark approval in December 2014. The Company also markets support catheters to facilitate crossing of peripheral and coronary arterial blockages, and retrograde access and guidewire retrieval devices used in the treatment of peripheral arterial blockages, including chronic total occlusions. The Company markets aspiration and cardiac laser catheters to treat blockages in the heart.
The Lead Management (LM) product line includes excimer laser sheaths, dilator sheaths, mechanical sheaths and accessories for the removal of pacemaker and defibrillator cardiac leads.
For more information, visit www.spectranetics.com.