December 28, 2014 2:43 PM 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
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 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.

Svelte Medical Systems, Inc. Announces Drug-Eluting Stent Utilizing New Class of Bioabsorbable Drug Coating Attains 0% Clinically-Driven Events Through 12-Months in First-In-Man Study

Svelte Medical Systems, Inc. announced that final 6 and 12-month results of the DIRECT first-in-man clinical study were presented by study principal investigator Dr. Mark Webster at the late-breaking clinical trials session of the EuroPCR meeting in Paris, France. No patients experienced clinically-driven TLR, TVR or MACE at 6-months, with results sustained through 12-months. It is believed the Svelte drug-eluting stent is the first ever to achieve 0% clinically-driven MACE through 12-months in a independent core-lab and DSMB adjudicated clinical study. The Svelte drug-eluting stent utilizes a new class of drug coating composed of a fully bioabsorbable, amino acid-based drug carrier mixed with the well-known anti-proliferative compound sirolimus. Amino acids occur naturally in the human body, providing a non-inflammatory and inherently bio-friendly drug-eluting platform. Unlike current-generation bioabsorbable coatings relying on hydrolysis for absorption, amino acids undergo gradual enzyme-based surface erosion with no bulk degradation or pH change activating an inflammatory response. Invasive imaging at 6-months in the DIRECT study corroborates these clinical outcomes, revealing stent volume obstruction of 2.7%, approximately one-half that observed in current-generation, market-leading drug-eluting stent first-in-man studies. Optical coherence tomography revealed 98% of stent struts were fully covered, indicative of low inflammation and consistent vessel healing. The DIRECT (Direct Implantation of Rapamycin-eluting stent with bio-Eroding Carrier Technology) study evaluated the Svelte drug-eluting stent mounted on a fixed-wire Integrated Delivery System (IDS) in 30 patients at 4 sites in New Zealand. Providing the lowest crimped stent profile on the market, the Svelte system facilitates use of the trans-radial approach and general downsizing of the access site, while allowing access to more difficult to cross and distal lesions. The IDS 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, thereby minimizing procedure time and cost. This balloon technology will also be available with a rapid-exchange delivery system at commercial launch. Approximately one-fifth of patients in the study were diabetic while one-half presented with Type B2 or C lesions. Procedural success was 100% and device success was 97%. Study results are published in the current issue of EuroIntervention, the official journal of EuroPCR and the European Association of Percutaneous Cardiovascular Interventions (EAPCI). The Svelte drug-eluting stent is currently under evaluation in the DIRECT II study. DIRECT II is a prospective, randomized, multi-center clinical study comparing the safety and efficacy of the Svelte drug-eluting coronary stent mounted on the IDS to Medtronic's Resolute Integrity(TM) drug-eluting stent. The DIRECT II study will enroll 159 patients at up to 20 clinical sites in Europe and Brazil to assess the primary endpoints of Target Vessel Failure (TVF) and in-stent Late Loss (LL). All patients are scheduled to receive 6-month clinical and angiographic follow-up, with clinical follow-up through 5-years. A subset of patients will receive optical coherence tomography (OCT) imaging at 6-months.

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