Svelte Medical Systems, a healthcare products manufacturer based in New Providence, New Jersey, announced that it had successfully treated the first patient in its Direct II drug-eluting stent clinical trial.
According to a press release by the company, Svelte Medical’s Direct II Phase II clinical trial was designed to test the efficacy of the Svelte device against Medtronic’s Resolute DES. The Svelte device is designed to automatically elute sirolimus, an anti-stenosis drug, through the use of a bioabsorbable carrier made of a special blend of amino acids. In comparison, the Resolute DES uses a polymer-based drug carrier.
In its press release, the company stated that it would enroll 159 patients in its Direct II trial at 20 different sites in Brazil and Europe. Primary endpoints of the study include in-stent late loss and target vessel failure. All participants in the study will receive a six-month angiographic and clinical follow-up. Patients will also be monitored for an additional five years.
Jack Darby is the CEO and president of Svelte Medical Systems. In prepared remarks, he said, "We believe our drug-eluting IDS, with its proprietary balloon and drug carrier technologies, represents an easy to use, best-in-class offering which will deliver procedural efficiencies and associated cost savings while demonstrating long-term clinical outcomes consistent with market-leading drug-eluting stents."
- Drowning in Big Data: Extracting Medical Device Quality and Safety Insights - Webcast
- Quality with Confidence – What You Need to Know About Digital Microscopes for Medical Device Quality Processes - Webcast
- Risk Management for Medical Device Manufacturers - Webcast
- 3 Steps for Designing the Ideal Medical Device Packaging System - Webcast
- Reducing Device Cost with Innovative Medical Materials - Webcast
- Automating your Quality Management System: Pitfalls & Essentials - Webcast