September 25, 2016 4:22 AM ET

Healthcare Equipment and Supplies

Company Overview of Svelte Medical Systems, Inc.

Company Overview

Svelte Medical Systems, Inc. engages in the design, development, and commercialization of balloon expandable stents for patients undergoing percutaneous coronary intervention (PCI) for the treatment of atherosclerosis. It offers SLENDER Integrated Delivery System (IDS), a drug-eluting coronary stent-on-a-wire integrated delivery system that downsizes catheters and is designed to facilitate transradial intervention (TRI); and DIRECT Rapid Exchange System (RX), a drug-eluting stent (DES) system that utilizes proprietary balloon designs to enhance direct stenting and high-pressure post-dilatations in the event a conventional wire-based approach to coronary stenting is preferred. The company was...

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
Vice President of Operations
Vice President of Quality Assurance and Regulatory Affairs
Vice President of Research & Development
Vice President of Scientific Affairs
Compensation as of Fiscal Year 2016.

Svelte Medical Systems, Inc. Key Developments

Svelte Medical Systems Announces European Launch of SLENDER IDS

Svelte Medical Systems, Inc. announced the commercial launch of the SLENDER Sirolimus-Eluting Coronary Stent-On-A-Wire Integrated Delivery System (IDS) to select accounts in Europe specializing in TRI. The first advance in stent delivery since the rapid-exchange catheter, SLENDER IDS is the world’s lowest profile drug-eluting stent (DES), designed to reduce the catheter size and steps necessary to perform percutaneous coronary intervention (PCI). SLENDER IDS will result in a paradigm shift in interventional cardiology. By combining the latest guide wire, delivery balloon, stent and drug coating technologies into a single ‘all-in-one’ fixed-wire system, SLENDER IDS achieves low profiles and performance unlike any other DES. Asahi ACT ONE™ wire technology provides precise steering while proprietary Balloon Control Band (BCB™) technology allows controlled balloon growth to safely perform direct stenting and high-pressure post-dilatation(s). DISCREET™ drug coating, applied to a highly conformable cobalt chrome stent, is composed of the well-studied drug sirolimus and a natural, amino acid-based polyesteramide (PEA) bioresorbable drug carrier proprietary to DSM Biomedical, a global leader in biomaterials science and regenerative medicine. In the DIRECT I and II clinical studies, exceptionally low TLR was observed while no deaths or stent thromboses were reported beyond 3 years. Svelte plans to begin enrollment of the DIRECT III post-market study during first quarter 2016 to evaluate the procedural efficiencies and 12-month clinical outcomes of SLENDER IDS in real-world patient populations in Europe. A rapid-exchange DES system with proprietary technology designed to facilitate direct stenting will also be commercialized in Europe in 2016. Svelte further plans to commence an IDE study in support of US PMA approval in 2016.

Svelte Medical Systems Reports Updates to Clinical Program

Svelte Medical Systems reported 1-year clinical results from the DIRECT II study were similar to those seen at 6-months, with non-inferiority clearly established. The company announced that target Lesion Failure (TLF), a primary clinical indicator of device efficacy, increased from 2.8% at 6-months to 3.7 % at 1-year in the Svelte arm, while TLF in the control arm reached 7.8% at the same 1-year time point. The Svelte arm also exhibited reduced procedure and device times, with trends toward reduced fluoroscopy time and contrast use compared with the control arm, confirming results observed in prior studies utilizing Svelte technologies. DIRECT II is a prospective, randomized, multi-center clinical study comparing the safety and efficacy of the Svelte drug-eluting coronary stent-on-a-wire Integrated Delivery System (IDS) and the Medtronic Resolute Integrity drug-eluting coronary stent in 159 patients undertaken in support of CE Mark certification of the Svelte IDS. Utilizing a fixed-wire design which provides the lowest crimped stent profile on the market, proprietary balloon technology for direct stenting and a new class of bioresorbable drug coating, the IDS is designed to optimize trans-radial interventions (TRI) and a 'slender' approach to PCI by downsizing catheter sizes used during intervention.

Svelte Medical Systems, Inc. Welcomes Richard Dakers to Board of Directors

Svelte Medical Systems, Inc. welcomed Richard Dakers of the Gary and Mary West Health Investment Fund to its board of directors.

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