SurModics, a US-based provider of medical devices and in-vitro diagnostic technologies, has completed the enrolment of the first patient in an early feasibility study of its SurVeil drug-coated balloon (DCB).
The study will enrol up to 15 patients to collect data on product safety and usability before concluding on the product design.
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The company has identified three clinical sites to participate in this early feasibility study for the SurVeil DCB.
The DCBs are considered instrumental in treating peripheral artery disease (PAD). It aims to administer the correct dosage of antiproliferative drug at the site of a lesion, and applies the drug uniformly to the arterial wall by reducing the drug release into the blood stream during the procedure.
The SurVeil DCB is the first complete vascular medical device developed by the company featuring its patented drug-excipient formulation for the balloon coating, and a new and proprietary manufacturing process for the coating applications.
It also includes the SurModics Serene low-friction, low-particulate hydrophilic coating on the catheter shaft.
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By GlobalDataSurModics Scientific Advisory Board chairman and Massachusetts General Hospital vascular medicine and intervention section head Kenneth Rosenfield said: "First and second generation DCBs demonstrated a biologic effect and improved patency in patients with PAD.
"The new generation of DCBs, which includes significant advances in technology, provides a great opportunity to further enhance patient outcomes."
Last year, the study was granted an investigational device exemption (IDE) approval by the FDA.
