In the News
Press Releases
October 17, 2020
OPTIMIZE Study Reports Lowest TLR Ever Achieved in an Investigational Device Exemption (IDE) Study with Svelte Medical System’s Bioresorbable Coated Drug-Eluting Coronary Stent
OPTIMIZE Pivotal Study 1 Year Outcomes Announced In the Late-Breaking Trials Session of TCT Connect.
Read MoreJune 5, 2019
Svelte Medical Systems Announces Final Patient Enrolled in Pivotal OPTIMIZE Study
OPTIMIZE is Evaluating the World’s First Drug-Eluting Stent-on-a-Wire and a Rapid Exchange Drug-Eluting Stent System in support of US Food and Drug Administration (FDA) and Japanese Regulatory Approvals for the Treatment of Atherosclerotic Coronary Lesions.
Read MoreJanuary 10, 2018
Svelte Medical Systems Announces First Patient Enrolled in Pivotal OPTIMIZE Study
OPTIMIZE is Evaluating the World’s First Drug-Eluting Stent-on-a-Wire and a Rapid Exchange Drug-Eluting Stent System in support of US Food and Drug Administration (FDA) and Japanese Regulatory Approvals for the Treatment of Atherosclerotic Coronary Lesions.
Read MoreMay 16, 2017
Svelte Medical Systems Reports Sustained Outstanding Outcomes in Clinical Studies
First-in-Man Study Using the World’s First Drug-Eluting Stent-on-a-Wire Completes 5-Year follow-up with 0% Major Adverse Cardiac Events; No Additional Revascularizations through 3 Years in DIRECT II Study.
Read MoreOctober 24, 2016
Svelte Medical Systems Announces CE Mark Certification of DIRECT RX
DIRECT RX Combines a New Class of Bioresorbable Drug Coating, Highly Conformable Stent Design and Proprietary Balloon Technology to Provide a Workhorse Coronary Drug-Eluting Stent (DES) Rapid-Exchange System Designed to Enhance Direct Stenting.
Read MoreJune 7, 2016
Robert Fischell, Co-Founder of Svelte Medical Systems, Honored at White House
Robert Fischell, a holder of more than 200 US and foreign medical patents, receives the National Medal of Technology and Innovation from President Obama.
Read MoreJanuary 19, 2016
Svelte Medical Systems Announces European Launch of SLENDER IDS
The World’s First Drug-Eluting Coronary Stent-on-a-Wire Integrated Delivery System Downsizes Catheters, Facilitates Transradial Intervention (TRI) and Maximizes Procedural Efficiency.
Read MoreDecember 15, 2015
Svelte Medical Systems Announces CE Mark Certification of SLENDER IDS
The World’s First Drug-Eluting Coronary Stent-on-a-Wire Integrated Delivery System Downsizes Catheters, Facilitates Transradial Intervention (TRI) and Maximizes Procedural Efficiency.
Read MoreMay 20, 2015
Svelte Medical Systems Announces Updates to Clinical Program
World’s First Drug-Eluting Coronary Stent-on-a-Wire Demonstrates Sustained Clinical Results, 0% Stent Thrombosis in DIRECT II Randomized, Controlled Study; Plans for IDE Study Revealed.
Read MoreMarch 19, 2015
Svelte Medical Systems Secures Financing; Richard Dakers Joins Board
All-insider round of investment funds ongoing operations and upcoming commercial activities in Europe. Richard Dakers of the West Health Investment Fund joins the company Board of Directors.
Read MoreFebruary 12, 2015
Svelte Medical Systems and ASAHI INTECC Announce Manufacturing and Co-Branding Agreements
Collaboration Features Latest ASAHI Technology in Design, Development and Supply of Core Wire & Coil Assembly for the Svelte Drug-Eluting Coronary Stent Fixed Wire Integrated Delivery System.
Read MoreSeptember 18, 2014
World’s First Integrated Delivery System Meets All Endpoints in the DIRECT II Randomized, Controlled Drug-Eluting Coronary Stent Study
Washington, D.C. – Svelte Medical Systems today reported that its drug-eluting coronary stent Integrated Delivery System (IDS), a new approach to Percutaneous Coronary Intervention (PCI) and the first advance in coronary stent delivery in nearly 20-years, met all DIRECT II study 6-month angiographic and clinical endpoints.
Read MoreMay 29, 2014
Svelte Medical Systems Announces Completion of 6-Month Follow-up in the DIRECT II Drug-Eluting Stent Study
New Providence, N.J. – Svelte Medical Systems today 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™ drug-eluting stent.
Read MoreMarch 10, 2014
West Health Investment Fund Joins Svelte Medical Systems Private Financing as Major Investor
New Providence, NJ – Svelte Medical Systems today announced that the Gary and Mary West Health Investment Fund has joined CNF Investments and New Science Ventures as major investors in the company.
Read More