Miami Lakes, FL 10/31/2023 - Cordis has announced enrollment of the first patient in its SELUTION4DeNovo IDE trial, the coronary de novo study for SELUTION SLR™ Drug-Eluting Balloon (DEB), the company’s novel sirolimus-eluting balloon. SELUTION4DeNovo is the first DEB de novo study to begin enrollment in the US, following receipt of conditional FDA Investigational Device Exemption (IDE) approval. The first patient has been enrolled by Dr. Samin K. Sharma, Director of Interventional Cardiology at the Mount Sinai Heart, New York. “We are very excited to be part of this important trial, which addresses a true need to be able to treat patients and reduce the number of stents offering the opportunity to uncage coronary arteries”
SELUTION4DeNovo is a prospective, randomized, controlled single-blind multicenter trial, designed to demonstrate the safety and efficacy of SELUTION SLR™ DEB for the treatment of de novo lesions in small coronary vessels. The study will enroll up to 910 randomized subjects and up to 30 subjects in a parallel angiographic sub study and up to 20 subjects in a parallel pharmacokinetic sub study. Patients will be enrolled at up to 80 sites in the US, Canada, Brazil, Japan, and Europe. A minimum of 50% of subjects will be enrolled in the US. (ClinicalTrials.gov Identifier: NCT05946629).
This study will complement the substantial experience that the company has already gained with the SELUTION DeNOVO Trial in Europe (ClinicalTrials.gov Identifier: NCT04859985). More than 1,800 patients, half of the 3,326 planned, have already been enrolled in this ground-breaking coronary randomized controlled study comparing SELUTION SLR™ DEB with any limus drug-eluting stent (DES). The study is powered to demonstrate superiority of SELUTION SLR™ DEB over DES in coronary de novo artery disease. This is the largest DEB study ever initiated and has the potential to change medical practice where implants (metal stents) have been the standard of care for more than 30 years.
Cordis is also studying the SELUTION SLR™ DEB for in-stent restenosis as part of the SELUTION4ISR IDE study. Over 170 patients have already enrolled in the SELUTION4ISR IDE Study including 40 US sites. "Use of DEBs in the treatment of coronary in-stent restenosis addresses the clear need for addressing restenosis without the use of additional stents. SELUTION4ISR along with the SLEUTION4DeNovo studies will provide important data on the efficacy and safety of sirolimus- eluting balloon with sustained drug release as a viable alternative to drug-eluting stent, leaving nothing behind post-PCI and eliminating in-stent restenosis and related complications" said Principal Investigator Dr. Ron Waksman, Professor of Cardiology at Georgetown University, Director of Cardiovascular Research at MedStar Heart and Vascular Institute, Washington DC and Chairman of the MedAlliance Coronary Study Steering Committee.
“Coronary de novo lesions are the largest potential opportunity for use of DEB’s: the data has demonstrated that there are certain indications where DES have been challenged clinically. Small vessels, long, and bi-furcated lesions and patients with diabetes or risk of high bleeding complications represent more than 50% of patients currently treated with DES, who may now benefit from this exciting new DEB technology” added Shar Matin, CEO of Cordis.
SELUTION SLR™ DEB’s unique technology involves MicroReservoirs which contain a mixture of biodegradable polymer intermixed with the anti-restenotic drug sirolimus applied as a coating to the surface of an angioplasty balloon. These MicroReservoirs have been designed to provide controlled and sustained release of the drug for up to 90 days.
SELUTION SLR™ DEB coronary, SFA and BTK platforms are commercially available in Europe, the Middle East, and a number of markets across Asia and Latin America and most other countries where the CE Mark is recognized. Over 40,000 units have already been used for patient treatment as part of clinical practice or clinical trials.
Cordis is a worldwide leader in the development and manufacturing of interventional vascular technology with a more than 60-year history of pioneering breakthrough cardiovascular technologies to treat millions of patients. With a reputation for clinical acumen, training, and service, Cordis established a legacy of innovation in high-quality and minimally invasive cardiovascular products and built a strong global footprint with operations in more than 70 countries around the world. Cordis is backed by private equity firms Hellman & Friedman and KKR. For more information, visit www.cordis.com.