OPTIMIZE is Evaluating the World’s First Drug-Eluting Stent-on-a-Wire and a Rapid Exchange Drug-Eluting Stent System in help 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 primary affected person in Svelte Medical System’s OPTIMIZE scientific examine, designed to additional assess the protection and effectiveness of the Svelte Drug-Eluting Stent (DES) Integrated Delivery System (IDS) and Rapid Exchange (RX) platforms. The randomized, managed OPTIMIZE examine is predicted to enroll roughly 2,000 sufferers at as much as 125 websites in the US, Japan and Europe in help of US and Japan regulatory approvals. The Svelte IDS and RX techniques make the most of low profile, extremely conformable stents and a brand new class of bioresorbable drug provider 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 value from coronary stent procedures. Both techniques maintain CE Mark certification and are commercially obtainable in Europe.
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“The profile, flexibility and total deliverability of the Svelte system is outstanding,” mentioned J.D. Corl, M.D., an interventional heart specialist at Christ Hospital who handled the primary affected person within the OPTIMIZE examine. “The added worth of a low-compliant supply balloon to deploy stents at larger pressures, lowering the necessity for conventional non-compliant post-dilatation balloons, is an actual profit to interventionalists.”
The OPTIMIZE examine builds on the constructive outcomes beforehand reported within the DIRECT I and DIRECT II research. DIRECT I, a first-in-man examine evaluating the feasibility of the Svelte IDS, accomplished 5-year follow-up with 0% clinically-driven MACE reported. DIRECT II, a randomized, multi-center examine evaluating the protection and efficacy of the Svelte IDS with the Medtronic Resolute Integrity DES, studies clinically-driven MACE of 3.7% and 9.8% by 3 years within the Svelte IDS and management DES arms, respectively. There has been no report of stent thrombosis within the roughly 2,000 sufferers handled with Svelte DES techniques in scientific and industrial settings.
“OPTIMIZE will probably be a landmark examine for interventional cardiology,” mentioned Dean Kereiakes, M.D., F.A.C.C., the Medical Director at Christ Hospital and principal investigator of the OPTIMIZE examine. “Not solely is it evaluating a completely new method to coronary stent supply using novel ideas and subsequent technology applied sciences, OPTIMIZE is the primary trial to guage, in a potential, randomized vogue, direct stenting in addition to the potential well being financial affect derived by streamlining PCI. Both the OPTIMIZE examine and the brand new know-how being evaluated are very thrilling.”
By combining a DES, balloon and wire right into a single, low-profile built-in system, the Svelte IDS has demonstrated the flexibility to cut back process time, distinction use, radiation publicity and adjunctive product use in registry research abroad. The OPTIMIZE examine will assess the security, efficacy and well being financial advantage of the Svelte IDS and RX techniques.
“We are grateful to the OPTIMIZE examine investigators for his or her collaboration and excited to convey our applied sciences to sufferers and physicians within the US and Japan,” mentioned Jack Darby, President and CEO of Svelte Medical Systems. “Our extremely differentiated platforms enhance procedural effectivity and cut back value whereas enhancing affected person outcomes and luxury, delivering worth to all constituents concerned in coronary stenting – sufferers, physicians, suppliers and payers.”
About Svelte Medical Systems
Headquartered in New Providence, New Jersey, Svelte Medical Systems (www.sveltemedical.com) is a privately-held firm engaged within the growth of extremely deliverable balloon expandable stents. Statements made on this press launch that look ahead in time or that specific beliefs, expectations or hopes relating to future occurrences or anticipated outcomes or advantages, are forward-looking statements. A lot of dangers and uncertainties, comparable to dangers related to product growth and commercialization efforts, outcomes of scientific trials, final scientific outcomes and advantage of the corporate’s merchandise to sufferers, market and doctor acceptance of the merchandise, mental property safety and aggressive product choices, may trigger precise occasions to adversely differ from the expectations indicated in these ahead trying statements.
About The Lindner Research Center
For the previous 28 years, The Carl and Edyth Lindner Center for Research and Education (Lindner Research Center) has offered modern medicines and medical know-how analysis masking a broad spectrum of circumstances from weight problems, diabetes, coronary illness, hypertension and hyperlipidemia to new vascular interventional gadgets, grownup stem cell therapies, structural coronary heart illness, cardiovascular surgical procedure, coronary heart failure and electrophysiology. Physicians on the Lindner Research Center have performed over 1,600 scientific trials together with a number of first-in-man and first-in-the-U.S. procedures, which have contributed to finest apply requirements for the care of sufferers. For info on present trials, please name 513-585-1777.
Svelte Medical Systems, Inc.
Jack Darby, 908-264-2012
President and CEO
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