Miami Lakes, FL 10/24/2023- Cordis, a worldwide leader in the development and manufacturing of interventional cardiovascular and endovascular technology, has announced completion of patient enrollment in SUCCESS PTA, its large post-market study with the SELUTION SLR™ Drug-Eluting Balloon (DEB) for the treatment of patients with peripheral artery disease (PAD). SELUTION SLR™ DEB is a novel sirolimus-eluting balloon that provides a controlled sustained release of drug, similar to that of a drug-eluting stent (DES).
The objective of the study is to collect ‘real-world’ safety, efficacy, health economics and patient reported quality-of-life data in over 700 patients with PAD treated with SELUTION SLR™ DEB. It is a single arm all-comers study including all lower limb indications (SFA; BTK; Foot) and will cover at least 50 sites in Europe, Asia, and South America. Patients will be followed-up at 30 days; six months; then every year out to five years.
The primary endpoint of the study is Clinically Driven Target Lesion Revascularization (CD-TLR) at 12 months. Secondary endpoints include device success and procedure success; Major Adverse Limb Events (MALE); and Target Limb Revascularization (TLR).
Data from the SUCCESS PTA Study will be part of the clinical evidence supporting CE Mark renewal under the European Medical Device Directive (MDR).
“Given the impressive performance of this novel device in earlier studies, we are very excited to see how SELUTION SLR™ DEB will perform in a larger group of patients in a real-world setting,” commented the study’s Principal Investigator Michael Lichtenberg, Arnsberg, Germany.
“This is the largest and most important study we have done for these BTK and SFA patients to date. We are very excited to partner with thought leaders globally to build an extensive compendium of clinical evidence that supports our groundbreaking SELUTION SLR™ DEB technology,” commented Shar Matin, CEO of Cordis.
SELUTION SLR™ DEB was awarded CE Mark Approval for the treatment of peripheral artery disease in February 2020 and for the treatment of coronary artery disease in May 2020. MedAlliance, acquired by Cordis in October 2023, was the first drug-eluting balloon company to receive FDA Breakthrough Designation status. In addition to the BTK and superficial femoral artery (SFA) indications for which the company received FDA IDE approval in May and August 2022, SELUTION SLR™ DEB received coronary in-stent restenosis (ISR) IDE approval in October 2022 and IDE approval for de novo coronary artery disease in January 2023.
Subsequent to achieving IDE Status, three FDA studies involving SELUTION SLR™ DEB are currently enrolling with a fourth, involving patients with coronary de novo artery disease, planned to start shortly. The latter will complement the substantial experience gained with the ground-breaking SELUTION DeNovo Trial in Europe, which has now enrolled over 1,660 patients, roughly half of the planned 3,326 patients. SELUTION DeNovo Trial compares the treatment strategy using SELUTION SLR™ DEB versus any limus drug-eluting stent [DES] [ClinicalTrials.gov Identifier: NCT04859985]. This study is designed to change medical practice, as the majority of de novo coronary lesions are currently treated with a permanent metallic stent.
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 on 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. Cordis’ proprietary CAT™ (Cell Adherent Technology) enables the MicroReservoirs to be coated onto balloons and efficiently transferred to adhere to the vessel lumen when delivered via expansion of the balloon.
SELUTION SLR™ DEB is commercially available in Europe, Asia, the Middle East, and the Americas (outside USA) and most other countries where the CE Mark is recognized. Over 40,000 units have been used for patient treatments in routine clinical practice or as part of coronary 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.