Surmodics has received an investigational device exemption (IDE) from the U.S. Food and Drug Administration (FDA) to initiate a pivotal clinical trial of the SurVeilâ„¢ drug-coated balloon (DCB).

The randomized trial will evaluate the SurVeil DCB for treatment for peripheral artery disease (PAD) in the upper leg compared to the Medtronic IN.PACT® Admiral® DCB.

The SurVeil DCB pivotal trial will be among the first trials in the U.S. to compare a next-generation DCB with a commercially-available DCB.

“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,” said Gary Ansel, MD, system medical chief of the Vascular Program at OhioHealth. “DCB therapy for patients with lower extremity PAD is growing rapidly, and while results have been encouraging there is significant room for improvement.”

The design of the SurVeil DCB reflects Surmodics’ long-standing industry leadership in the development of surface technology for vascular medical devices.

The device includes a proprietary drug-excipient formulation for the balloon coating and is manufactured using a proprietary process to improve coating uniformity. Pre-clinical data have shown a three to five times higher target tissue drug concentration, a more evenly distributed and durable drug effect, and lower incidence of downstream drug concentrations compared to control DCBs.

“Surmodics’ expertise and capabilities in surface technology are evident in the design and pre-clinical performance of the SurVeil DCB,” said Kenneth Rosenfield, MD, Section head, Vascular Medicine and Intervention at Massachusetts General Hospital and chair of the Surmodics clinical advisory board. “We’re excited about Surmodics’ capability to improve on the performance of existing DCBs.”

The SurVeil DCB early feasibility study (EFS), conducted in the U.S., met its primary endpoint by demonstrating peak paclitaxel plasma concentrations post-index procedure. Consistent with pre-clinical data, systemic levels were low and cleared rapidly. No safety issues attributed to the product have been reported.

“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,” said Gary Maharaj, president and CEO of Surmodics.

“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 pre-clinical 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.”

The development of the SurVeil DCB is a major step forward in Surmodics’ strategy to transform from a surface modification technology company to a provider of whole-product solutions for its medical device customers. In 2015, the company acquired Creagh Medical, an innovative developer and manufacturer of balloon catheters located in Ireland, and U.S.-based NorMedix, a manufacturer of differentiated specialty catheter and device delivery systems.

Surmodics now has complete capabilities for design, development and high-volume manufacturing of a wide variety of highly differentiated balloon catheter solutions that utilize the company’s advanced surface technology.

About the SurVeil DCB Pivotal Trial

The objective of the SurVeil DCB pivotal trial, TRANSCEND, is to evaluate the safety and effectiveness of the device for treatment of subjects with symptomatic PAD due to stenosis of the femoral and/or popliteal arteries. The clinical study will be used to support regulatory approvals (U.S. and Europe) and reimbursement.

The trial will enroll up to 446 subjects at approximately 60 sites in the U.S. and 18 outside the U.S. Study participants will be randomized to receive either treatment with SurVeil DCB or IN.PACT Admiral DCB. The primary efficacy endpoint of the trial is primary patency, defined as a composite of freedom from restenosis and clinically-driven target lesion revascularization (TLR) through 12 months post-index procedure. All randomized subjects will be followed through 36 months post-index procedure. Surmodics expects to initiate enrollment in the TRANSCEND clinical trial in the fourth quarter of calendar 2017.

The trial will be led by national co-principal investigators Kenneth Rosenfield, MD, Section Head, Vascular Medicine and Intervention at Massachusetts General Hospital, and Gary Ansel, MD, System Medical Chief of the Vascular Program at OhioHealth. Marianne Brodmann, MD, Substitute Head of the Division of Angiology, Department of Internal Medicine, Medical University of Graz, Graz, Austria, is the European principal investigator.

The SurVeil DCB is not available for sale in the U.S. and is for investigational use only.