PARIS--(BUSINESS WIRE)--Svelte Medical Systems, Inc. today reported 1-year clinical results from the DIRECT II study were similar to those seen at 6-months, with non-inferiority clearly established. Target Lesion Failure (TLF), a primary clinical indicator of device efficacy, increased from 2.8% at 6-months to 3.7% at 1-year in the Svelte arm, while TLF in the control arm reached 7.8% at the same 1-year time point. The Svelte arm also exhibited reduced procedure and device times, with trends toward reduced fluoroscopy time and contrast use compared with the control arm, confirming results observed in prior studies utilizing Svelte technologies.
DIRECT II is a prospective, randomized, multi-center clinical study comparing the safety and efficacy of the Svelte drug-eluting coronary stent-on-a-wire Integrated Delivery System (IDS) and the Medtronic Resolute Integrity™ drug-eluting coronary stent in 159 patients undertaken in support of CE Mark certification of the Svelte IDS. Utilizing a fixed-wire design which provides the lowest crimped stent profile on the market, proprietary balloon technology for direct stenting and a new class of bioresorbable drug coating, the IDS is designed to optimize trans-radial interventions (TRI) and a ‘slender’ approach to PCI by downsizing catheter sizes used during intervention.
“The sustained clinical outcomes observed in DIRECT II, coupled with no reports of stent thrombosis dating back to the first-in-man study, are reassuring initial signals relating to safety,” said Stefan Verheye, MD, PhD, who is co-director of the Antwerp Cardiovascular Institute at the Middelheim Hospital in Antwerp, who presented the data at the EuroPCR meeting in Paris. “The Svelte IDS offers unique clinical as well as procedural efficiency benefits, and we look forward to integrating it into our practice once it is commercially approved.”
“The Svelte IDS represents the first paradigm shift in coronary stent delivery since the rapid-exchange catheter, and I look forward to trialing the device here in the US,” said Dean Kereiakes, MD, FACC, FSACI, who is medical director at The Christ Hospital Heart & Vascular Center/The Lindner Research Center in Cincinnati, Ohio and will serve as co-principal investigator of Svelte’s pivotal IDE study once approved in the US. “In a time where emphasis is continually placed on improving efficiencies and reducing costs while augmenting patient outcomes and comfort – the accelerated adoption of trans-radial PCI in the US is one example of this – the IDS offers interesting possibilities to patients, physicians and payers.”
Svelte recently announced a manufacturing and co-branding agreement with Asahi Intecc, a leader in interventional guide wire development, to incorporate Asahi wire tip technology with the IDS. The collaboration features ASAHI’s latest ACTONE™ wire technology in the design, development and supply of core wire and coil assemblies for the Svelte IDS to optimize performance for direct stenting. Laura Mauri, MD, MSc, Associate Professor of Medicine at Harvard Medical School and co-principal investigator of Svelte’s proposed IDE study noted, “The Svelte IDE study, once approved, will provide angiographic insight on direct stenting in a large-scale, randomized, controlled setting, an area presently lacking in meaningful data. When coupled with the procedural benefits using this approach, this data may impact current thinking on coronary stenting.”
Svelte is currently working with the FDA to receive approval to initiate an IDE study with the IDS. The company expects the IDS to receive CE Mark certification during the second-half of 2015.
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.