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Teleflex wins FDA nod for next-gen peripheral snares, launches in US

Teleflex (NYSE:TFX) said today it won FDA 510(k) clearance for its Expro Elite and Sympro Elite peripheral interventional snares and that it launched the devices in the US. Both newly cleared snares are next-generation versions of 0.035″ interventional snares launched in the US in 2008 by Vascular Solutions, which is now a wholly-owned subsidiary of Teleflex. The Expro Elite snare is designed to use a helical loop for all-direction capturing, and the Sympro Elite snare is designed to use a 90-degree loop which remains coaxial to the vessel, the Wayne, Penn.-based company said. Both devices are designed for use in the cardiovascular system and hollow viscus to retrieve or manipulate objects using minimally invasive surgical procedures. “We are excited to introduce to the market our enhanced versions of the Expro Elite and Sympro Elite Interventional Snares, which build on nearly a decade of reliable performance in the cath lab. Both devices feature greatly enhanced pull force for superior handling in challenging procedures. Both snare products feature a durable nitinol construction that retains its shape and adds strength, a radiopaque gold-plated tungsten coil and tip for enhanced visibility, 1:1 torque response for controlled positioning and better access to distal targets, and a unique locking handle that facilitates secure capture,” prez &interventional division GM Stewart Strong said in a press release. Last December, Teleflex said it inked...
Source: Mass Device - Category: Medical Devices Authors: Tags: Food & Drug Administration (FDA) Regulatory/Compliance Vascular Teleflex Source Type: news

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