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Svelte's Stent-on-a-Wire Gains CE Mark
Approval Represents a Milestone for This Novel Device
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Both unexpanded stents are 2.5mm x 18mm: standard DES (L) and
Svelte (R) |
December 15, 2015 -- Svelte Medical Inc., a relatively small device manufacturer based in New Jersey today achieved a milestone: the CE Mark approval that will allow the company to commercialize its novel stent-on-a-wire in Europe and other countries that accept the CE Mark. Svelte hopes to submit a PMA application to the FDA in 2016.
The approval was based mainly on the results of the DIRECT II study of 159 patients which showed no stent thrombosis at four years and efficacy, measured by target vessel failure and in-stent late loss, at least as good as the standard drug-eluting stents currently on the market. (The earlier First in Man DIRECT I study looked at an additional 30 patients.)
The stent itself features several innovations. It has a bioabsorbable drug coating of sirolimus. And it is based on the Svelte Acrobat (pictured here), originally fashioned by Dr. Tim Fischell, whose team also created the CYPHER DES platform.
The Svelte device is literally a stent-on-a-wire, crimped to a very narrow profile. This narrow profile offers several advantages:
- The stent does not need to be advanced over a guide wire, because the stent IS the guide wire. The Svelte technology allows the metal scaffold to be crimped so tightly, that it in effect becomes part of the guide wire itself. And the guide wire is manufactured by Asahi, a major manufacturer in this field. Once the guide wire is advanced to the blockage, the stent can be inflated immediately, saving time and reducing fluoroscopic radiation exposure.
- Because the stent can be deployed using the direct stenting technique, no balloon is needed to first open up the blockage, in order to make room for the stent. The stent is delivered directly to the blockage and deployed, again saving time and fluoroscopy exposure.
- The SLENDER IDS utilizes a biodegradable polymer to elute the sirolimus drug. Once the polymer has disappeared, the SLENDER acts as a bare metal stent, avoiding possible inflammatory responses that can compromise an otherwise positive initial outcome
- Finally, because the stent can be introduced with a narrow 5F system, it is ideal for the transradial artery approach which is gaining in utilization throughout the world. Using a 5F system reduces the incidence of arterial spasm and site-related bleeding, making the procedure easier and safer.
It can take a very long time to bring a novel product to this stage, and a high degree of perseverance on the part of the manufacturer and investigators is necessary. This reporter first heard about the Svelte device when interviewing Dr. Tim Fischell in 2007 - eight years ago!
This morning's press release from Svelte Inc. follows:
Svelte Medical Systems Announces CE Mark Certification of SLENDER IDS™
The World’s First Drug-Eluting Coronary Stent-on-a-Wire Integrated Delivery System Downsizes Catheters, Facilitates Transradial Intevention (TRI) and Maximizes Procedural Efficiency
December 15, 2015 -- New Providence, New Jersey -- Svelte Medical Systems, Inc. today announced it received CE Mark certification of the SLENDER Sirolimus-Eluting Coronary Stent-On-A-Wire Integrated Delivery System (IDS) for the treatment of coronary artery disease. The first advance in stent delivery since the rapid-exchange catheter, SLENDER IDS is the world’s lowest profile drug-eluting stent (DES), reducing the catheter size necessary to perform percutaneous coronary intervention (PCI) and facilitating transradial intervention (TRI) in more patients. Incorporating Asahi guide wire technology, a specialized balloon design and a new class of bioresorbable drug carrier from DSM Biomedical, SLENDER IDS is designed to enhance direct stenting, enabling interventional cardiologists to extracts steps, time and cost from stenting procedures.
“SLENDER IDS is an entirely new approach to coronary stenting, offering unique clinical and procedural benefits which we look forward to integrating into our practice,” said Stefan Verheye, MD, PhD, principal investigator of the DIRECT II study supporting CE Mark certification and Co-Director of the Antwerp Cardiovascular Institute at the Middelheim Hospital in Antwerp, Belgium. “No reports of stent thrombosis dating back nearly 4 years to the first-in-man study are reassuring signals relating to safety, and product efficacy appears as good as any current generation DES. The unique attributes of this product help us in our ongoing efforts to optimize patient care.”
SLENDER IDS combines the latest guide wire, delivery balloon and DES technologies into a single ‘all-in-one’ fixed-wire system. 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.
“Adding value in the modern healthcare environment requires new technologies to improve efficiency and reduce cost while enhancing patient outcomes and comfort. SLENDER IDS is a highly differentiated platform delivering value to all constituents involved in coronary stenting – patients, physicians, providers and payers,” said Jack Darby, President and CEO of Svelte Medical Systems, Inc. “We are extremely pleased to achieve the CE Mark for SLENDER IDS and look forward to introducing it in cath labs in Europe.”
Svelte plans to commercialize SLENDER IDS in select accounts in Europe and commence an IDE study in support of PMA approval in 2016. A rapid-exchange DES system with proprietary technology designed to facilitate direct stenting will also be commercialized in Europe 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.
Reported by Burt Cohen, December 15, 2015 (corrected from an earlier version regarding the number of patients studied in DIRECT II) |
