Spectranetics Announces FDA Approval of Stellarex™ Drug-Coated Balloon
COLORADO SPRINGS, Colo., The Spectranetics Corporation today announced receipt of U.S. Food and Drug Administration (FDA) Pre-Market Approval (PMA) of the Stellarex™ drug-coated balloon (DCB), 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 shown safety and efficacy in a cohort of patients which included a higher preponderance of diabetics and core-lab defined severely calcified lesions in the US IDE trial. These results, in combination with the cohort of patients studied in the European Randomized Controlled Trial, demonstrate the Stellarex DCB is safe and effective in diverse patient populations when addressing symptomatic femoropopliteal disease,” stated Dr. Prakash Krishnan, ILLUMENATE Pivotal Trial’s Co-Principal Investigator, Mount Sinai in New York.
Dr. Sean Lyden, ILLUMENATE Pivotal Trial’s Co-Principal Investigator, Cleveland Clinic, Cleveland, Ohio added, “The ILLUMENATE Pivotal Trial treated a challenging patient population with a low paclitaxel drug dose. When considering options, I think most clinicians would prefer to use a lower drug dose if they can also achieve great patency results.”
Throughout the ILLUMENATE Trial Series, Stellarex DCB’s EnduraCoat™ Technology demonstrates both safety and efficacy with consistently high patency rates and low clinically driven target lesion revascularization rates in a range of lesion complexities and patient co-morbidities. The device offers both hybrid paclitaxel crystallinity and a durable excipient to provide efficient drug transfer, effective drug residency with high coating durability and minimal particulate loss.
“The Stellarex DCB delivers top-tier clinical results for common to complex patients. As the only commercially available DCB with two reported randomized controlled trials, Stellarex has demonstrated durability with consistently high patency rates in a wide range of patients," said Scott Drake, President and CEO, Spectranetics. "Our customers refer to Stellarex as a no-compromise solution. This next generation DCB provides proven treatment backed by robust clinical evidence.”
“Spectranetics is a provider of proven solutions to manage the challenges of crossing lesions, preparing vessels, and treating even the most complex coronary and peripheral lesion morphologies. We are always focused on better patient care, and with today’s FDA approval, the Stellarex DCB becomes a formidable competitor in the drug-coated balloon market, and a proven solution for those suffering with PAD,” said Scott Hutton, Sr. Vice President & General Manager, Spectranetics.
The Stellarex DCB enhances Spectranetics’ diversified suite of clinical solutions to treat complex cardiovascular conditions and expands its market opportunity in the projected $1 billion DCB global market.
About the ILLUMENATE Clinical Program
There are five ILLUMENATE clinical studies evaluating the safety and efficacy of the Stellarex DCB platform and supporting United States regulatory filings:
- The ILLUMENATE EU Randomized Study is a prospective, randomized controlled, multi-center trial with 328 patients. The primary safety and effectiveness endpoints at 12 months were met and superiority over PTA was demonstrated in both. The 12-month primary patency rate was 83.9% (188/224) in the Stellarex arm vs. 60.6% (40/66) in the PTA arm (P<0.001), per Kaplan Meier (KM) estimate the patency rate at day 365 was 89.0% vs. 65.0%, respectively (log-rank p<0.001).
- The ILLUMENATE Pivotal Study is a prospective, randomized controlled, multi-center trial with 300 patients enrolled. The cohorts were well match and included a preponderance of patients with diabetes (50%) and severely calcified lesions (44%). The primary safety and effectiveness endpoints at 12 months were met and superiority over PTA was demonstrated in both. The primary patency rate was significantly higher in the Stellarex group at 76.3% (135/177) vs. 57.6% (53/92) for PTA (p=0.003). The 12-month primary patency rate, per KM estimate at day 365 was 82.3% in the DCB arm vs. 70.9% in the PTA arm (p=0.002).
- The ILLUMENATE Global Study is a prospective, multi-center, single-arm study with 371 patients enrolled. The 12-month primary patency rate was 81.4% per KM estimate.
- 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 per KM estimate 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 and showed all patients had detectable paclitaxel levels after DCB deployment that declined rapidly within the first hour (54.4±116.9 ng/mL to 1.4±1.0 ng/mL).
Sources
Spectranetics Corporation
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