The annual Transcatheter Cardiovascular Therapeutics conference is under way in Washington, D.C., with late-breaking study results beginning Oct. 29. We’ll update this post throughout the day as new results come in, so be sure to check back for the latest news out of TCT 2016.
After stents took center stage Day 1, with a raft of studies covering the latest on the bioresorbable front, transcatheter valve replacements were the focus on Day 2. Day 3 saw a wider variety of topics, featuring big-name devices for structural heart repair and peripheral artery disease at the Transcatheter Cardiovascular Therapies conference:
Stellarex drug-coated balloon from Spectranetics bests PTA at 1 year
The Stellarex drug-coated balloon made by Spectranetics (NSDQ:SPNC) beat out percutaneous transluminal angioplasty in the 300-patient Illumenate pivotal study reported today at the meeting.
The study followed a complex group of patients over 12 months to evaluate the low-dose balloon’s efficacy and safety. Nearly 50% of the patient population had diabetes, 43.9% had high rates of severe calcification, 45% suffered from cardiovascular disease, and 18% had renal insufficiency. The primary safety endpoint was a composite of freedom from device- and procedure-related death at 30 days and freedom from target limb major amputation and clinically driven target lesion revascularization; the primary efficacy endpoint was a composite of primary patency, freedom from restenosis and clinically-driven TLR.
Patients were randomized to either receive the Stellarex balloon or percutaneous transluminal angioplasty. Just more than 92% of the Stellarex-treated cohort met the safety endpoint, compared to 83.2% for the control group. The primary efficacy endpoint was reached for 82.3% of the Stellarex group, compared with 70.9% of the PTA-treated group.
“First-generation drug-coated balloons forced us to make a choice between top-tier clinical outcomes and the potential safety advantages of a lower drug dose. Based on the compelling Stellarex DCB study results, we no longer need to compromise,” co-principal investigator Dr. Sean Lyden, of the Cleveland Clinic, said in prepared remarks. “In the most challenging patient population studied in a DCB Investigational Device Exemption trial, the next-generation Stellarex DCB achieved remarkable clinical outcomes. I am very excited these results could be obtained given the high proportion of severely calcified lesions and co-morbidities.”
“Severe calcification has been viewed as the Achilles heel of drug-coated balloons,” added Spectranetics president & CEO Scott Drake. “Our U.S. pivotal trial data provides compelling evidence that Stellarex achieves top-tier patency even in very complex patients. These outcomes are a significant step forward in our effort to improve patient care and lead the way in clinical science.”
The Colorado Springs-based company also said today that it filed for pre-market approval from the FDA for Stellarex, which Spectranetics bought from Covidien as part of the latter company’s sale to Medtronic last year.