Svelte Medical Systems has initiated European clinical trial for its 'Stent-on-a-Wire' (SOAW) cobalt–chromium bare metal stent, at the Thoraxcenter Research Center in Rotterdam, the Netherlands. The company anticipates receiving CE Mark for the bare metal SOAW by the middle of 2010 and plans to initiate clinical activities for the drug eluting stent in 2011.
The SOAW delivery system represents a deliverable, low profile system that can reduce procedural costs and can potentially lower the rate of stent thromb.
The company plans to introduce its drug eluting stent (DES) with non-inflammatory properties instead of utilizing typical polymeric coatings, which are known to significantly irritate the vessel lining.
Additionally, the company reports that Tim Shannon, former president of Mentice, has joined the company as vice president for Worldwide Sales & Marketing and Michael Johnson, former managing director and CFO of J.P. Morgan Chase, has joined the organization as CFO and Treasurer.
Serruys, professor and chief of Interventional Cardiology at Erasmus Medical center in the Netherlands, said: “This device will simplify the stenting procedure and allow us to downsize the guiding catheter in many patients. The company anticipates initiating additional trials in Brazil and Columbia during the first quarter of 2010.”
Mark Pomeranz, president and CEO of Svelte Medical Systems, said: “We are pleased to announce such significant news at Svelte. The initiation of our clinical trial enhances our track record of delivering on strategic milestones and the addition of Mr. Shannon and Mr. Johnson rounds out the final pieces of the management team which will drive the company’s growth moving forward.
“We are well positioned to capitalize on the market’s need for a lower profile, cost effective and safe alternative to current coronary stenting techniques.”