Svelte Medical Systems initiates European clinical trial for SOAW delivery system

Jan 9 2010

Svelte Medical Systems, Inc. is pleased to announce that it has initiated its European clinical trial at the Thoraxcenter Research Center in Rotterdam, the Netherlands for its “Stent-on-a-Wire” (SOAW) cobalt–chromium Bare Metal Stent. The SOAW delivery system represents a more deliverable, very low profile system that can reduce procedural costs and can potentially lower the rate of stent thrombosis. Professor Serruys, Chief of Interventional Cardiology at Erasmus Medical center in the Netherlands commented that “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.

“this device will simplify the stenting procedure and allow us to downsize the guiding catheter in many patients.”

The company also 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. Svelte Medical anticipates receiving CE Mark for the first generation bare metal SOAW by the middle of 2010 and plans to initiate clinical activities for the DES in 2011.

Additionally, the company announces that Mr. Tim Shannon, former President of Mentice, Inc. has joined the company as Vice President – Worldwide Sales & Marketing and Mr. Michael W. Johnson, former Managing Director and CFO of J.P. Morgan Chase, has joined the organization as CFO and Treasurer. The addition of these two proven executives strengthens a management team that has over 90 years experience in bringing highly successful medical devices to the market in both entrepreneurial environments and large organizations.

“We are extremely 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,” said Mark Pomeranz, President and CEO of Svelte Medical Systems, Inc.