The World's First Drug-Eluting Coronary Stent-on-a-Wire Integrated Delivery System Downsizes Catheters, Facilitates Transradial Intervention (TRI) and Maximizes Procedural Efficiency
January 19, 2016 07:30 AM Eastern Standard Time
NEW PROVIDENCE, N.J.--(BUSINESS WIRE)--Svelte Medical Systems, Inc. today announced the commercial launch of the SLENDER Sirolimus-Eluting Coronary Stent-On-A-Wire Integrated Delivery System (IDS) to select accounts in Europe specializing in TRI. The first advance in stent delivery since the rapid-exchange catheter, SLENDER IDS is the world's lowest profile drug-eluting stent (DES), designed to reduce the catheter size and steps necessary to perform percutaneous coronary intervention (PCI).
"SLENDER IDS will result in a paradigm shift in interventional cardiology," said Ferdinand Kiemeneij, MD, PhD, who treated the first patient with the recently CE Mark certified SLENDER IDS at Tergooi Hospital in Blaricum, The Netherlands, and was the first interventional cardiologist ever to perform PCI via transradial approach more than 20 years ago. "SLENDER IDS is a platform designed to improve patient care by breaking with current interventional standards, and I am proud to be involved with this project."
Giovanni Amoroso, MD, PhD, a practicing interventional cardiologist at OLVG Hospital in Amsterdam, The Netherlands, and Principal Investigator of the DIRECT III post market study evaluating the clinical and procedural efficiency of SLENDER IDS in a real world setting added, "Downsizing is the future of interventional cardiology, and SLENDER IDS is the first ultra-low profile DES. The ability to reduce catheter size without compromise to performance minimizes vascular trauma and enables use of the transradial approach, with all of its well-known clinical benefits, across broader subsets of patients. This makes for a much more pleasant patient experience."
Dr. Kiemeneij and Dr. Amoroso are pioneers in the use of 'slender' techniques – the utilization of lower profile devices and TRI to minimize trauma – for PCI in Europe. Together they host free-of-charge 'slender' workshops each month, inviting other practicing interventional cardiologists to learn the techniques and products used for 'slender' PCI, observe cases and manage same-day patient discharge.
By combining the latest guide wire, delivery balloon, stent and drug coating technologies into a single 'all-in-one' fixed-wire system, SLENDER IDS achieves low profiles and performance unlike any other DES. Asahi ACT ONE™ wire technology provides precise steering while proprietary Balloon Control Band (BCB™) technology allows controlled balloon growth to safely perform direct stenting and high-pressure post-dilatation(s). DISCREET™ drug coating, applied to a highly conformable cobalt chrome stent, is composed of the well-studied drug sirolimus and a natural, amino acid-based polyesteramide (PEA) bioresorbable drug carrier proprietary to DSM Biomedical, a global leader in biomaterials science and regenerative medicine. In the DIRECT I and II clinical studies, exceptionally low TLR was observed while no deaths or stent thromboses were reported beyond 3 years.
"SLENDER IDS is a highly differentiated platform that fundamentally changes the way coronary stenting procedures are performed, and it will ultimately transform the DES landscape. We are excited to see physicians in the real-world share our enthusiasm for this novel platform," said Jack Darby, President and CEO of Svelte Medical Systems, Inc.
Svelte plans to begin enrollment of the DIRECT III post-market study during Q1 2016 to evaluate the procedural efficiencies and 12-month clinical outcomes of SLENDER IDS in real-world patient populations in Europe. A rapid-exchange DES system with proprietary technology designed to facilitate direct stenting will also be commercialized in Europe in 2016. Svelte further plans to commence an IDE study in support of US PMA approval in 2016.
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.
Svelte Medical Systems, Inc.
Jack Darby, 908-264-2012
President and CEO