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Svelte and ASAHI INTECC to Collaborate on Fixed Wire Stent System; Ideal for Transradial Approach
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Svelte Acrobat (R) w/standard stent (L) |
February 15, 2015 -- Svelte Medical Systems, Inc., manufacturers of the unique drug-eluting coronary stent fixed wire Integrated Delivery System (IDS), sometimes called a "stent-on-a-wire," and ASAHI INTECC, the top Japanese maker of guidewires used in interventional procedures, have announced a manufacturing and co-promotion agreement. ASAHI will design and manufacture the wire tip of the Svelte IDS stent, using its latest ACTONE technology, and also will be partnering with Svelte in the stents promotion.
This announcement represents a significant milestone for Svelte, since their IDS technology now will be combined with that of the world's premier guide wire provider. ASAHI's guide wire technology is well-known for its highly refined precise performance, qualities which have made ASAHI the market leader in guide wires.
Svelte Medical states that:
"The ASAHI wire tip technology will materially enhance deliverability of the IDS, benefitting both patients and interventional cardiologists. The Asahi wire tip technology is the final piece in our high quality, cutting-edge fixed-wire IDS system which already incorporates a bioresorbable drug coating and specialized high-pressure balloon technology. With its ultra-low profile, the IDS is designed to enhance transradial interventions (TRI) and 'slender' PCI along with direct stenting. These techniques have been demonstrated to improve clinical outcomes and enhance patient comfort while reducing bleeding complications and time to ambulation. Also material to the healthcare environment in which we live today, the IDS extracts hard and soft costs (by reducing the use of ancillary products such as conventional guide wires and PTCA balloons as well as overall procedure time) from stenting procedures. The IDS represents the first advance in stent delivery technology since the rapid-exchange catheter (some 20 years ago) and offers the potential to change how stenting procedures are performed."
Based on the very positive clinical 6-month outcomes seen in the DIRECT II randomized, controlled trial, Svelte is expecting to be able to launch the drug-eluting coronary stent IDS in Europe later this year. The company is also working with regulatory agencies in the U.S. and Japan to start pivotal trials for eventual approval in those countries as well.
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 can be deployed using the direct stenting technique, where no balloon is needed to first open up the blockage, making room for the stent. The stent is delivered directly to the blockage and deployed, saving several steps, time, and fluoroscopy exposure.
A second advantage that speaks to the current growth in adoption of the transradial wrist approach is that, because of the narrow profile, the stent can be introduced with a 4F or 5F system, making it ideal for the radial artery approach, even in smaller women. In fact, although operators in the original DIRECT study were given the choice of femoral or radial access, all 30 procedures were done via the transradial approach.
This press release from Svelte Medical Systems follows:
Svelte Medical Systems and ASAHI INTECC Announce Manufacturing and Co-Branding Agreements
Collaboration Features Latest ASAHI Technology in Design, Development and Supply of Core Wire & Coil Assembly for the Svelte Drug-Eluting Coronary Stent Fixed Wire Integrated Delivery System
February 12, 2015 -- New Providence, New Jersey -- Svelte Medical Systems, Inc., a privately held company engaged in the development of highly deliverable balloon-expandable stents, and ASAHI INTECC CO., LTD. (Securities Code 7747, Second Section, Tokyo and Nagoya Stock Exchange) today announced Svelte and ASAHI INTECC USA, INC., a subsidiary company of ASAHI INTECC CO., LTD., executed formal agreements relating to the manufacture and co-branding of the Svelte drug-eluting coronary stent fixed wire Integrated Delivery System (IDS). The collaboration will feature ASAHI's latest ACTONE wire technology in the design, development and supply of core wire and coil assemblies for the Svelte IDS.
The Svelte IDS is designed to optimize transradial (through the wrist) interventions (TRI) and the 'slender' approach to Percutaneous Coronary Intervention (PCI). With the lowest-crimped stent profile on the market, the Svelte IDS allows physicians to downsize catheter sizes used during procedures. In Japan and parts of Europe, TRI is the default interventional strategy. In the U.S., the number of TRI procedures is growing rapidly, increasing from less than 5 percent of procedures in 2007 to more than 25 percent today. Svelte is working with regulatory authorities to secure approval to conduct pivotal studies with the IDS in Japan and the US and expects the IDS to be commercially available in Europe in 2015.
"Our collaboration with ASAHI INTECC takes our fixed wire stent program to the next level at a time when global support for TRI procedures and the 'slender approach' is growing rapidly, especially in the U.S.," said Jack Darby, President and CEO of Svelte Medical Systems. "The Svelte fixed wire IDS represents the first change in coronary stent delivery since the advent of the rapid exchange catheter. By leveraging our innovations with world-class ASAHI INTECC expertise and wire technology, we will create a truly unique drug-eluting coronary stent platform which enhances patient outcomes while minimizing costs to the healthcare system."
"Svelte Medical Systems has a unique and promising drug-eluting coronary stent platform," said Masahiko Miyata, president and chief executive officer, ASAHI INTECC CO., LTD. "With the unique fusion of Asahi advanced wire technology and components and novel Svelte technology, this partnership should improve procedure outcomes worldwide."
ASAHI INTECC CO., LTD. specializes in wire drawing, wire forming, torque transmission and coating processes for percutaneous transluminal coronary angioplasty (PTCA) guidewires.
About ASAHI INTECC CO., LTD.
ASAHI INTECC CO., LTD. develops, manufactures and sells original brand guidewires and catheters used in less invasive cardiovascular, peripheral vascular, abdominal vascular and neurovascular procedures, as well as original equipment manufacturer (OEM) products and medical components. The original brand PTCA guidewires have top market share in Japan. In the industrial device field, ASAHI INTECC CO., LTD. supplies ultrafine stainless wire rope used in a wide range of applications such as office automation equipment and automobiles. ASAHI INTECC CO., LTD. identifies its mission as continuing to provide the world market with its "Only One" technology and "Number One" product for less invasive procedures to improve patients' quality of life.
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, February 15, 2015
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