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vascular solutions inc (VASC) Key Developments

Vascular Solutions, Inc. Announces FDA 510(K) Clearance of Zigiwire Access Guidewire System

Vascular Solutions Inc. announced that the ZigiWire access support guidewire system has received FDA 510(k) clearance. The company is designed to facilitate placement and exchange of catheters during peripheral diagnostic or interventional procedures. The company plans to launch ZigiWire through its 101-member direct U.S. sales force in January 2015. ZigiWire is manufactured for the company by VadisWire Corp. The ZigiWire guidewire support systems employ a novel method of establishing progressive and secure support wire access into most arterial vascular anatomy in an efficient and time saving manner. Through any standard 0.038" compatible catheter lumen, the operator advances a floppy-style lead wire for initial engagement of the target vessel which is then followed by up to two additional wires to achieve the desired level of guidewire support.

Vascular Solutions Receives FDA Clearance for VSI Radial Introducer Sheath

Vascular Solutions Inc. has received the FDA 510(k) clearance for VSI Radial introducer sheath 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 rocedures. Vascular Solutions plans to launch the VSI Radial introducer sheath through its 101-member direct US sales force in January 2015. The VSI Radial introducer sheath is manufactured for Vascular Solutions by LePu Medical Technology (Beijing) Co. Ltd. under an exclusive US distribution agreement. 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 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 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.

Vascular Solutions Receives FDA Clearance for New Turnpike Catheters

Vascular Solutions Inc. has received 510(k) clearance from the FDA for its Turnpike catheters, a new line of catheters designed for use in coronary and peripheral interventions. Vascular Solutions expects to launch the Turnpike catheters in January following clinical evaluations to occur in December. The Turnpike catheters are single-lumen catheters with a shaft constructed from two layers of polymer that encapsulate both a braid and a dual-layer coil. The Turnpike is available in two versions, a Soft Tip and a Hard Tip version, both of which advance over an 0.014" guidewire. The Soft Tip version extends the catheter's braid and dual-layer coil into a soft, radiopaque distal tip which, following a non-tapered polymer-only section, gradually tapers to a smooth distal edge. The Soft Tip version has been designed for use in small and tortuous vessels in which the catheter's flexible tip tracks over the guidewire around tight curves in the artery. The Hard Tip version terminates with a gold-plated, stainless steel distal tip. The Hard Tip version of Turnpike has been designed for use in cases in which an 0.014" guidewire has advanced through a lesion but the advancement of any other device over the guidewire is difficult. The Hard Tip version is available in two configurations: one with a threaded distal tip designed to provide additional rotational advancement and one with a smooth distal tip for minimal friction during advancement. The Turnpike catheters are intended to be used to access discrete regions of the coronary and/or peripheral vasculature. The catheters may be used to facilitate placement or exchange of guidewires and to subselectively infuse/deliver diagnostic and therapeutic agents.

Vascular Solutions Receives 510(k) Clearance for Gel-Block(TM) 10X Embolization Product

Vascular Solutions Inc. announced that it has received 510(k) clearance from the U.S. Food and Drug Administration for Gel-Block 10x embolization pledgets for use in the treatment of hypervascular tumors and arteriovenous malformations (AVMs). Vascular Solutions is launching the product in the U.S. this week. The Gel-Block 10x version builds on Vascular Solutions' original Gel-Block embolization device launched in the U.S. in July 2012. The new 10x version offers 10 pledgets in a vial as a configuration that enhances value and customer ease-of-use. The original Gel-Block, which will remain available, is packaged with two pledgets per device, pre-loaded into delivery tubes. Gel-Block 10x consists of ten pre-formed, ready-to-use gelatin foam pledgets supplied in a vial with a delivery syringe. The pledgets are designed for precise delivery through standard catheters to occlude blood flow within target vessels. The product is offered in three sizes to accommodate multiple catheter sizes with inner diameters as small as 0.021" and up to 0.038". Vascular Solutions' Gel-Block products were designed to meet the needs of interventional radiologists who previously had been required to cut and roll sheets of gelatin foam to form pledgets for embolization procedures due to the lack of pre-made, off-the-shelf gelatin embolization pledgets. Embolization is the technique of deliberately blocking blood flow within a vein or artery to achieve a therapeutic effect. Standard catheters are used to reach the targeted treatment area, and then a blocking agent is injected into the vessel to reduce or stop blood flow.

Vascular Solutions Inc. Presents at 26th Annual Piper Jaffray Healthcare Conference, Dec-02-2014 10:30 AM

Vascular Solutions Inc. Presents at 26th Annual Piper Jaffray Healthcare Conference, Dec-02-2014 10:30 AM. Venue: The New York Palace Hotel, 455 Madison Ave, New York, NY 10022, United States. Speakers: Howard C. Root, Co-Founder, Chief Executive Officer and Director.


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