Healthcare Industry News:  drug-eluting stent 

Devices Interventional Cardiology

 News Release - December 20, 2012

Svelte Medical Systems Announces Treatment of First Patient in the ACES Effectiveness Study

NEW PROVIDENCE, N.J.--(Healthcare Sales & Marketing Network)--Svelte® Medical Systems today announced treatment of the first patient in the ACES (Acrobat Coronary stent system effectiveness European Study) clinical trial by Victor Legrand, MD, PhD at CHU Liege in Liege, Belgium. ACES is a randomized, controlled study designed to demonstrate the positive clinical benefit and impact on resource utilization of the Svelte Acrobat Integrated Delivery System (IDSTM) compared with conventional coronary stent devices in patients with lesions eligible for direct stenting. Up to 300 patients will be enrolled in the study at 12 sites in France, Belgium and Spain.

A fixed-wire based system, the Svelte coronary stent IDS is low profile and highly flexible, navigating through the vasculature similar to a traditional guidewire, allowing physicians to ‘direct-stent’ coronary artery lesions and eliminate several steps in their current stenting procedures. Non-randomized data presented at medical symposia earlier this year suggest the Svelte IDS significantly reduces radiation exposure, contrast use, adjunctive interventional product use and overall procedure time when compared with conventional stent systems.

“The Svelte IDS is being used in our lab, and with appropriate patient and lesion selection, should offer reduced procedure time and cost, as well as reduced contrast use and radiation exposure, which is important to patients and physicians alike. The ACES study will specifically assess patient and physician benefit and may become a reference study given the increasing focus on healthcare costs,” said Jean Fajadet, MD, PhD, Director of Interventional Cardiology at Clinique Pasteur, Toulouse, France and principal investigator of the ACES study. “Once the DES version of the Svelte IDS is available, the system’s low profile will also become of greater benefit in treating more challenging and distally located lesions.”

The Svelte IDS is low profile and highly flexible, facilitating use of the transradial approach and general downsizing of the access site, while allowing access to more difficult to cross and distal lesions. The system also includes proprietary balloon control band technology providing uniform and controlled balloon growth, even at high pressures, to safely facilitate direct stenting and use of the system for post-dilatation.

“Demonstrating procedure time and cost savings in a randomized setting with enhanced clinical outcomes and operator ease-of-use will definitively establish the value of the Svelte IDS. We look forward to the outcomes of the ACES study,” added Jack Darby, President and CEO of 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. The Svelte IDS represents the first material advance in stent delivery systems in the last fifteen years and is designed to realize the clinical, time and cost-savings benefits of direct stenting in a single platform. The company also plans to commercialize its drug-eluting stent on a conventional rapid-exchange delivery platform incorporating its proprietary balloon control band technology.

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.


Source: Svelte Medical Systems

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