Svelte Medical Systems Announces First Patient Enrolled in Pivotal OPTIMIZE Study

The Christ Hospital, Lindner Research Center in Cincinnati, Ohio, has 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 United States, Japan, and Europe in support of U.S. and Japanese 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.
 
“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 percent 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 percent and 9.8 percent through three 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.”

Headquartered in New Providence, N.J., Svelte Medical Systems is a privately-held company engaged in the development of highly deliverable balloon expandable stents.
 
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.