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.
NEW PROVIDENCE, N.J.–(BUSINESS WIRE)–January 10, 2018–
The Christ Hospital, Lindner Research Center in Cincinnati, Ohio, enrolled the first patient in Svelte Medical System’s OPTIMIZE clinical study, designed to further assess the safety and effectiveness of the Svelte Drug-Eluting Stent (DES) Integrated Delivery System (IDS) and Rapid Exchange (RX) platforms. The randomized, controlled OPTIMIZE study is expected to enroll approximately 2,000 patients at up to 125 sites in the US, Japan and Europe in support of US and Japan regulatory approvals. The Svelte IDS and RX systems utilize low profile, highly conformable stents and a new class of bioresorbable drug carrier eluting sirolimus. The fixed-wire Svelte IDS, the world’s lowest profile DES, downsizes catheters to facilitate transradial intervention (TRI) and direct stenting, extracting steps, time and cost from coronary stent procedures. Both systems hold CE Mark certification and are commercially available in Europe.
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“The profile, flexibility and overall deliverability of the Svelte system is remarkable,” said J.D. Corl, M.D., an interventional cardiologist at Christ Hospital who treated the first patient in the OPTIMIZE study. “The added value of a low-compliant delivery balloon to deploy stents at higher pressures, reducing the need for traditional non-compliant post-dilatation balloons, is a real benefit to interventionalists.”
The OPTIMIZE study builds on the positive outcomes previously reported in the DIRECT I and DIRECT II studies. DIRECT I, a first-in-man study evaluating the feasibility of the Svelte IDS, completed 5-year follow-up with 0% clinically-driven MACE reported. DIRECT II, a randomized, multi-center study comparing the safety and efficacy of the Svelte IDS with the Medtronic Resolute Integrity DES, reports clinically-driven MACE of 3.7% and 9.8% through 3 years in the Svelte IDS and control DES arms, respectively. There has been no report of stent thrombosis in the approximately 2,000 patients treated with Svelte DES systems in clinical and commercial settings.
“OPTIMIZE will be a landmark study for interventional cardiology,” said Dean Kereiakes, M.D., F.A.C.C., the Medical Director at Christ Hospital and principal investigator of the OPTIMIZE study. “Not only is it evaluating an entirely new approach to coronary stent delivery utilizing novel concepts and next generation technologies, OPTIMIZE is the first trial to evaluate, in a prospective, randomized fashion, direct stenting as well as the potential health economic impact derived by streamlining PCI. Both the OPTIMIZE study and the new technology being evaluated are very exciting.”
By combining a DES, balloon and wire into a single, low-profile integrated system, the Svelte IDS has demonstrated the ability to reduce procedure time, contrast use, radiation exposure and adjunctive product use in registry studies overseas. The OPTIMIZE study will assess the safety, efficacy and health economic benefit of the Svelte IDS and RX systems.
“We are grateful to the OPTIMIZE study investigators for their collaboration and excited to bring our technologies to patients and physicians in the US and Japan,” said Jack Darby, President and CEO of Svelte Medical Systems. “Our highly differentiated platforms improve procedural efficiency and reduce cost while enhancing patient outcomes and comfort, delivering value to all constituents involved in coronary stenting – patients, physicians, providers and payers.”
About Svelte Medical Systems
Headquartered in New Providence, New Jersey, Svelte Medical Systems (www.sveltemedical.com) is a privately-held company engaged in the development of highly deliverable balloon expandable stents. Statements made in this press release that look forward in time or that express beliefs, expectations or hopes regarding future occurrences or anticipated outcomes or benefits, are forward-looking statements. A number of risks and uncertainties, such as risks associated with product development and commercialization efforts, results of clinical trials, ultimate clinical outcomes and benefit of the company’s products to patients, market and physician acceptance of the products, intellectual property protection and competitive product offerings, could cause actual events to adversely differ from the expectations indicated in these forward looking statements.
About The Lindner Research Center
For the past 28 years, The Carl and Edyth Lindner Center for Research and Education (Lindner Research Center) has provided leading-edge medicines and medical technology research covering a broad spectrum of conditions from obesity, diabetes, coronary disease, hypertension and hyperlipidemia to new vascular interventional devices, adult stem cell therapies, structural heart disease, cardiovascular surgery, heart failure and electrophysiology. Physicians at the Lindner Research Center have conducted over 1,600 clinical trials including multiple first-in-man and first-in-the-U.S. procedures, which have contributed to best practice standards for the care of patients. For information on current trials, please call 513-585-1777.
Svelte Medical Systems, Inc.
Jack Darby, 908-264-2012
President and CEO