|
Svelte Launches Its Slender IDS Stent-on-a-Wire System in Europe
1st Advance in Stent Delivery Since Rapid-Exchange Catheter
World’s Lowest Profile Drug-Eluting Stent (DES)
|
 |
Both unexpanded stents are 2.5mm x 18mm: standard DES (L) and
Svelte's SLENDER IDS (R) |
January 24, 2016 -- New Jersey-based Svelte Medical Systems, Inc. announced this week the launch of its novel SLENDER IDS stent-on-a-wire in Europe and other countries that accept the CE Mark. Svelte is planning to submit a PMA application to the US FDA this year.
The SLENDER IDS gained the CE Mark last month and the company is now making the product available to select accounts in Europe that specialize in the transradial approach. In a press release (reprinted below) transradial pioneer Dr. Ferdinand Kiemeneij said, "SLENDER IDS is a platform designed to improve patient care by breaking with current interventional standards." And transradialist, Dr. Giovanni Amoroso, added, "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."
With the transradial (wrist) approach gaining traction worldwide, the SLENDER IDS is positioned to become a significant player in the stent arena.
The December approval of the SLENDER IDS 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 stent itself features several innovations. It has a bioabsorbable drug coating of sirolimus. And it is based on the Svelte Acrobat (pictured above), 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 - nine years ago!
This week's press release from Svelte Medical Systems, Inc. follows:
Svelte Medical Systems Announces European Launch of SLENDER IDS™
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 -- New Providence, New Jersey -- 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).
Dr. Ferdinand Kiemeneij |
“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.”
Dr. Giovanni Amoroso |
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.
Reported by Burt Cohen, January 24, 2016 |
