Medical devices provider SurModics has recruited first patient in an early feasibility study of its SurVeil drug-coated balloon (DCB).
The trial is part of the company’s strategy to translate its medical device business from a provider of device coatings to offer differentiated whole-product solutions to medical device customers.
In late 2015, SurModics obtained investigational device exemption (IDE) approval for the study from the US Food and Drug Administration (FDA).
The company selected three clinical sites to carry out the trial, which will include up to 15 patients and allow for the collection of data on product safety and usability before finalization of the product design.
The SurVeil DCB features the company’s new coating formulation for interventional vascular treatment of peripheral artery disease (PAD).
The balloon also includes the firm’s Serene low-friction and low-particulate hydrophilic coating on the catheter shaft.
It is claimed to be the first complete vascular medical device developed, which will be clinically tested by the company.
SurModics president and CEO Gary Maharaj said: "We are pleased with the progress we made enrolling the first patient in this study of our proprietary SurVeil DCB.
"We are proud to be on the path to offering highly differentiated whole-products solutions to our medical device customers."
SurModics said the SurVeil DCB is not available for sale in the US and is for investigational use only.