Surmodics (NSDQ:SRDX) said today that it won investigational device exemption from the FDA to launch a pivotal trial of its SurVeil drug-coated balloon.
The trial is slated to compare the Eden Prairie, Minn.-based company’s device with Medtronic‘s (NYSE:MDT) In.Pact Admiral drug-coated balloon for patients with peripheral artery disease in the upper leg.
“By providing a head-to-head comparison with today’s market-leading DCB, the Transcend trial will answer clinically important questions about the relative performance of DCBs,” Dr. Gary Ansel, system medical chief of the vascular program at OhioHealth, said in prepared remarks. “DCB therapy for patients with lower extremity PAD is growing rapidly, and while results have been encouraging there is significant room for improvement.”
The SurVeil drug-coated balloon makes use of a proprietary drug-excipient formulation and a proprietary manufacturing method to boost coating uniformity, according to Surmodics.
Preclinical data has shown that the balloon more efficiently delivers drugs to the target tissue and lowers downstream drug concentrations compared to control devices, the company reported.
“Surmodics’ expertise and capabilities in surface technology are evident in the design and pre-clinical performance of the SurVeil DCB,” Dr. Kenneth Rosenfield, chair of the Surmodics clinical advisory board, said. “We’re excited about Surmodics’ capability to improve on the performance of existing DCBs.”
“Surmodics’ decision to pursue the EFS in the U.S. demonstrated our confidence in the device and we are excited to be moving this into the pivotal trial,” president & CEO Gary Maharaj added. “The next-generation technology in the SurVeil DCB aims to improve drug transfer and effect on the arterial wall with a lower drug dose and a reduction in the amount of drug reaching tissue outside the area of treatment. We have been extremely satisfied with our preclinical and EFS results and look forward to working with our investigators in this trial to further evaluate the safety and efficacy compared to standard-of-care DCB therapy.”
