Svelte® Medical Systems has received conditional approval from the FDA to begin a pivotal IDE study to evaluate the safety and effectiveness of the Svelte IDS in approximately 370 patients at up to 30 investigative sites in the US.
New Jersey company, Svelte Medical Systems engages in the development of highly deliverable balloon expandable stents. Svelte claims its IDS represents the first material advance in stent delivery systems in the last fifteen years and is designed to realise the clinical, time and cost-savings benefits of direct stenting in a single platform.
The Svelte IDS combines a wire, balloon and stent into a single ‘All-In-One’ system. The low profile and highly flexible IDS navigates through the vasculature similar to a traditional guidewire to allow physicians to ‘direct-stent’ coronary artery lesions and eliminate several steps from conventional stenting procedures – thereby reducing procedure time and cost.
Data presented at medical symposia suggest the Svelte IDS significantly reduces radiation exposure, contrast use, adjunctive interventional product use and overall procedure time when compared with conventional stent systems.
“We are pleased to have earned approval from the FDA to initiate our pivotal study and look forward to collaborating with our clinical partners to demonstrate the clinical, procedural and cost savings benefits of our IDS technology,” said Jack Darby, President and CEO of Svelte. “Given the ever-increasing time constraints and cost pressures confronting cardiac cath labs, we are very confident the Svelte IDS offers an impactful alternative to maximize efficiency while providing best-in-class technology and outcomes.”
The Svelte IDS utilising a bare metal stent received CE Mark certification in 2010 and is commercially available in select European and Latin American markets. The company completed enrollment in the DIRECT study, a First-in-Man evaluation of its drug-eluting stent (DES) utilising a bioabsorbable drug carrier, and expects to initiate a European-based clinical study in support of CE Mark certification of the system later this year. This DES will be offered on both IDS and conventional rapid-exchange platforms incorporating the company’s proprietary Balloon Control Band (BCB) technology upon commercial release.
Source: Svelte Medical Systems Inc., Business Wire