FDA Approves Spectranetics' Stellarex Drug-Coated Balloon
July 26, 2017—The Spectranetics Corporation announced receipt of US Food and Drug Administration premarket approval (PMA) of the Stellarex drug-coated balloon (DCB), which is designed to restore and maintain blood flow to the superficial femoral and popliteal arteries in patients with peripheral arterial disease (PAD).
United States regulatory approval was supported by the ILLUMENATE clinical studies evaluating the safety and efficacy of the Stellarex DCB platform.
Prakash Krishnan, MD, the ILLUMENATE Pivotal Trial’s Coprincipal Investigator, commented in the company’s press release, “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 United States investigational device exemption 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.”
Sean Lyden, MD, also serving as&nbscoprincipal investigator, 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.”
According to Spectranetics, 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, multicenter trial with 328 patients. The primary safety and effectiveness endpoints at 12 months were met and superiority over percutaneous transluminal angioplasty (PTA) was demonstrated in both. The 12-month primary patency rate was 83.9% (188/224) in the Stellarex arm versus 60.6% (40/66) in the PTA arm (P < .001), per Kaplan Meier estimate the patency rate at day 365 was 89% versus 65%, respectively (log-rank P < .001).
- The ILLUMENATE Pivotal Study is a prospective, randomized controlled, multicenter trial with 300 patients enrolled. The cohorts were well matched 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) versus 57.6% (53/92) for PTA (P = .003). The 12-month primary patency rate, per Kaplan Meier estimate at day 365 was 82.3% in the DCB arm versus 70.9% in the PTA arm (P = .002).
- The ILLUMENATE Global Study is a prospective, multicenter, single-arm study with 371 patients enrolled. The 12-month primary patency rate was 81.4% per Kaplan Meier estimate.
- The ILLUMENATE First-In-Human Study was a nonrandomized, multicenter study that enrolled 80 patients. In the predilatation arm (n=50), the primary patency rate per Kaplan Meier 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).
On June 28, Royal Philips and Spectranetics announced that they have entered into a definitive merger agreement under which Philips will tender offers to shareholders for all issued and outstanding shares of Spectranetics in a deal estimated at €1.9 billion.