Surmodics announces global approvals of 0.014” low-profile PTA balloon dilation catheter

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Surmodics has received US Food and Drug Administration (FDA) 510(k) and CE mark clearance for its 0.014” low-profile percutaneous transluminal angioplasty (PTA) balloon dilation catheter, designed for peripheral angioplasty procedures. The company is making this product available for distribution in the coming months.

Surmodics says that its 0.014” PTA balloon catheter “offers best-in-class deliverability and lesion crossing by leveraging the company’s proprietary Serene hydrophilic coating, unmatched for low friction and particulates.” The company’s proprietary balloon and catheter technology, combined with Surmodics’ advanced processes, ensures ultra-low tip entry and crossing profile with smooth transitions, to achieve best-in-class product performance.

“Surmodics is focused on providing next-generation devices to address the growing need for minimally invasive treatment of peripheral artery disease,” said Gary Maharaj, President and CEO of Surmodics. “We are confident this highly deliverable, low-profile PTA catheter will provide physicians an effective new tool for accessing and crossing even the most complex peripheral lesions.”

The development of the Surmodics 0.014” low-profile PTA catheter is a step forward in the company’s strategy to be a provider of whole-product vascular solutions for its medical device customers. Following acquisitions of Creagh Medical and NorMedix, Surmodics says that it will now have “complete capabilities for design, development and high-volume manufacturing of a wide variety of highly differentiated balloon catheter and specialty catheter solutions”.

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