SurModics wins FDA, CE Mark for low-profile PTA balloon dilation cath

SurModics (NSDQ:SRDX) said today it won both FDA 510(k) clearance and CE Mark clearance in the European Union for its 0.014″ low-profile percutaneous translumioal angioplasty balloon dilation catheter with plans to launch the device in the coming months.

The newly launched PTA ballon catheter comes equipped with the company’s Serene hydrophilic coating, allowing for low friction and particulates, the Eden Prairie, Minn.-based company said.

SurModics said the clearance and coming launch of the low-profile PTA cath is a continuation of the company’s strategy to supply whole-product vascular solutions.

“Surmodics is focused on providing next-generation devices to address the growing need for minimally invasive treatment of peripheral artery disease. We’re 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,” prez & CEO Gary Maharaj said in a press release.

In July, Surmodics said it won investigational device exemption from the FDA to launch a pivotal trial of its SurVeil drug-coated balloon.

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