endovascular.es

Título: Vascular Solutions Announces FDA 510(k) Clearance of VSI Radial Introducer Sheath
Fecha: 08-12-2014
- Line of 17 models of the VSI Radial™ introducer sheath targets vascular access needs in the rapidly-growing radial artery catheterization market
- Developed and manufactured by LePu Medical of Beijing, China, building on the successful initial collaboration for the Vasc™ Band radial hemostat
- Vascular Solutions expects to launch the VSI Radial introducer sheath in January
MINNEAPOLIS, Dec. 8, 2014 (GLOBE NEWSWIRE) -- Vascular Solutions, Inc. (Nasdaq:VASC) today announced that the VSI Radial introducer sheath has received FDA 510(k) clearance for use in the introduction of guidewires and catheters into a vein or artery. The VSI Radial introducer sheath is specifically designed for patients undergoing transradial catheterization procedures. Vascular Solutions plans to launch the VSI Radial introducer sheath through its 101-member direct U.S. sales force in January 2015.
The VSI Radial introducer sheath is manufactured for Vascular Solutions by LePu Medical Technology (Beijing) Co., Ltd, the developer of the device, under an exclusive U.S. distribution agreement.
'We congratulate LePu Medical on achieving 510(k) clearance for the VSI Radial introducer sheath, and we look forward to launching this second product manufactured by LePu Medical for the radial catheterization market in the U.S.,' said Howard Root, Chief Executive Officer of Vascular Solutions. 'Vascular Solutions has focused on building a suite of products for use in radial procedures, and the launch of the VSI Radial introducer sheath builds on our very successful initial collaboration with LePu Medical on the Vasc Band radial hemostat that began in 2012.'
All 17 models of the VSI Radial introducer sheath contain a hydrophilic-coated introducer sheath and dilator, and the device will be available in three kit options. The Standard Kit option, designed for the single-wall micro-puncture ('modified Seldinger') technique, consists of 9 models that include a sheath, dilator, guidewire and 21G needle. The Access Kit option, designed for the double-wall micro-puncture technique ('through-and-through puncture' or 'traditional Seldinger' technique) consists of six models that include a sheath, dilator, polymer-coated guidewire, IV catheter needle, and syringe. The 035 Kit option, designed for converting a 4F or 5F diagnostic procedure into a 6F interventional procedure, consists of two models that include a sheath, dilator and 0.035' guidewire.
Adoption of radial access has become a recent focus for many cardiac catheterization labs in the U.S. due to growing physician acceptance of the technique, improved patient comfort, widespread availability of specialized radial catheters, and the integration of radial access into practice guidelines and fellowship programs. According to a study by the Society for Cardiovascular Angiography and Interventions (SCAI), radial access accounted for less than 3% of all diagnostic and interventional cath lab procedures performed in the U.S. in 2009. Since then, radial access has become one of the fastest-growing procedures in the U.S. cath lab market. According to a study published in Circulation, by the third quarter of 2012 more than 16% of all U.S. catheterization procedures were being performed through the radial artery. Based on feedback from its own customer base, Vascular Solutions believes radial access now represents more than 20% of all catheterization procedures performed in the U.S., which still significantly lags other developed markets, such as Japan at more than 60%, Canada at more than 50%, and Western European countries at more than 40%.
About LePu Medical
LePu Medical Technology (Beijing) Co., Ltd., was established in 1999 to develop, manufacture, and market medical devices, with a concentration in cardiac therapy. Today, the company's products include drug-delivery stents, catheters, guidewires, occlusive devices, prosthetic heart valves, pacemakers, and cardiac in vitro diagnostic products. In October 2009, LePu listed on the ChiNext of the Shenzhen Stock Exchange. LePu has more than 3,000 employees and is headquartered in Beijing's Changping Technology Park.
For additional information, connect to LePu's English language website athttp://en.lepumedical.com.
About Vascular Solutions
Vascular Solutions, Inc. is an innovative medical device company that focuses on developing unique clinical solutions for coronary and peripheral vascular procedures. The company's product line consists of more than 80 products in three categories: catheter products, hemostat products and vein products. Vascular Solutions delivers its products to interventional cardiologists, interventional radiologists, electrophysiologists, and vein specialists through its direct U.S. sales force and international independent distributor network.
The information in this press release contains forward-looking statements that involve risks and uncertainties. Our actual results could differ materially from those anticipated in these forward-looking statements. Important factors that may cause such differences include those discussed in our Annual Report on Form 10-K for the year ended December 31, 2013 and other recent filings with the Securities and Exchange Commission. The risks and uncertainties include, without limitation, risks associated with the need for adoption of our new products, lack of sustained profitability, exposure to intellectual property claims, significant variability in quarterly results, exposure to possible product liability claims, the development of new products by others, doing business in international markets, the availability of third party reimbursement, and actions by the FDA.
For further information, connect to www.vasc.com.
CONTACT: Phil Nalbone, VP
Vascular Solutions, Inc.
pnalbone@vasc.com
(763) 656-4371
Fuente: endovascular.es

endovasculares.es