March 01, 2015 8:18 AM ET

Healthcare Equipment and Supplies

Company Overview of Svelte Medical Systems, Inc.

Company Overview

Svelte Medical Systems, Inc. designs and develops balloon expandable stents for the treatment of atherosclerosis. It develops an integrated delivery system that navigates coronary arteries like a guide wire, as well as simplifies the stenting procedure. The company also develops drug-eluting stents. Its markets its products in the European Union; and selected South American countries, such as Brazil. Svelte Medical Systems, Inc. was founded in 2007 and is based in New Providence, New Jersey.

675 Central Avenue

Suite 2

New Providence, NJ 07974

United States

Founded in 2007

Phone:

908-264-2194

Fax:

908-728-9981

Key Executives for Svelte Medical Systems, Inc.

Chief Executive Officer, President and Director
Chief Operating Officer
Vice President of Quality Assurance
European Business Director
Vice President of Operations
Compensation as of Fiscal Year 2014.

Svelte Medical Systems, Inc. Key Developments

Svelte Medical Systems and Asahi Intecc USA Sign Manufacturing and Co-Branding Deal

Svelte Medical Systems and Asahi Intecc reported that Svelte and Asahi Intecc USA., a subsidiary company of Asahi Intecc, executed formal agreements relating to the manufacture and co-branding of the Svelte drug-eluting coronary stent fixed wire Integrated Delivery System (IDS). The collaboration will feature ASAHI's ACTONE wire technology in the design, development and supply of core wire and coil assemblies for the Svelte IDS.

Svelte Medical Systems Announces Completion of Six-Month Follow-Up in the Direct II Drug-Eluting Stent Study

Svelte Medical Systems announced completion of primary endpoint 6-month follow-up in DIRECT II (Direct Implantation of Rapamycin-Eluting stents with bioresorbable drug Carrier Technology), a prospective, randomized, multi-center clinical study comparing the safety and efficacy of the Svelte drug-eluting coronary stent Integrated Delivery System (IDS) to Medtronic's Resolute Integrity(TM) drug-eluting stent. DIRECT II builds upon the positive results of the DIRECT I first-in-man study where the Svelte drug-eluting coronary stent IDS continues to demonstrate durable outcomes with 0% clinically-driven MACE reported through 2-years. Providing the lowest crimped stent profile on the market, the Svelte IDS facilitates use of the trans-radial approach and 'slender' stenting while minimizing procedure time and cost. The IDS combines a thin-strut cobalt chromium stent with a fully bioresorbable drug carrier made of amino acids found naturally in the human body and the well-studied compound sirolimus (rapamycin) mounted on an integrated-wire delivery system. The system also incorporates proprietary Balloon Control Band (BCB) technology providing uniform and controlled balloon growth, even at high pressures, to safely perform direct stenting as well as high-pressure post-dilatation. The DIRECT II study enrolled 159 patients at 18 clinical sites in Europe to assess the primary endpoints of Target Vessel Failure (TVF) and in-stent Late Loss (LL). All patients were scheduled to receive 6-month clinical and angiographic follow-up, with clinical follow-up continuing through 5-years, with a subset of patients receiving optical coherence tomography (OCT) imaging at 6-months.

Svelte Medical Systems Announces Enrollment Complete in the DIRECT II Drug-Eluting Stent Study

Svelte Medical Systems announced enrollment of the final patient in the DIRECT II (Direct Implantation of Rapamycin-Eluting stents with bioabsorbable drug Carrier Technology) clinical study. DIRECT II is a prospective, randomized study comparing the safety and efficacy of the Svelte drug-eluting coronary stent Integrated Delivery System (IDS) to the Medtronic Resolute Integrity(TM) drug-eluting stent in 159 patients at 19 investigative sites. The study builds on the positive results of the DIRECT I first-in-man study which evaluated the Svelte drug-eluting coronary stent IDS in 30 patients in New Zealand. The Svelte system met all study endpoints in DIRECT I while demonstrating in-stent neointimal volume obstruction of 2.7% at 6-months, a one-third to one-half reduction in volumetric obstruction observed in similar studies with drug-eluting stents. Clinical outcomes reflected the strong angiographic findings, with 0% clinically driven MACE reported through 18-months.

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