FDA Approves IDE for SurModics’s Drug Coated Balloon

Eden Prairie, Minn.-based SurModics Inc., which makes medical devices and in vitro diagnostic technologies, has earned U.S. Food and Drug Administration (FDA) Investigational Device Exemption (IDE) approval to move forward in pursuing its first-in-human early feasibility study using the SurModics Surveil drug-coated balloon (DCB).

Drug-coated balloons treat peripheral artery disease. The aim of a DCB is to deliver the correct dosage of antiproliferative drug at the site of a lesion, and apply the drug uniformly to the arterial wall. To do this, the DCB must minimize unintended release of the drug into the blood stream during the procedure. Factors that may affect DCB performance include the ability of the excipient to preserve and release the drug at the appropriate time during the procedure, uniformity of the coating application on the balloon, and consistency of the paclitaxel drug on the balloon.

The development of the Surveil DCB is a major step forward in the company’s strategy to transform from a surface modification technology company to a provider of whole-product solutions to the medical device industry, company officials said. This approval allows the company to take the steps required to start an early feasibility clinical trial. SurModics has identified its clinical investigators and is developing plans for up to three clinical sites in the United States and expects to enroll the first patient in the second quarter of fiscal 2016.

The Surveil DCB includes a SurModics-proprietary 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.

“We are excited to have reached this milestone for the SurVeil DCB. Our decision to conduct the early feasibility study in the United States reflects our confidence in the advanced drug delivery capability of the device that has been demonstrated in promising pre-clinical research,” said Gary Maharaj, president and CEO of SurModics. “We are proud to use the early feasibility study pathway established by the FDA and have been very satisfied with the interactions and responsiveness of the Agency. This IDE approval allows us to start the process of working with U.S. clinical sites and investigators.”

“While the utilization of DCB therapy is growing rapidly and the clinical results for patients with lower extremity PAD are very encouraging, there are real opportunities to improve upon the early generation DCB technologies that are currently available,” said Kenneth Rosenfield, M.D., section head, vascular medicine and intervention at Massachusetts General Hospital, and chair of the SurModics clinical advisory board. “We are excited about SurModics’ technology, and their efforts to improve upon the performance of existing DCBs in the interest of further enhancing patient outcomes.”

Though SurModics has long provided surface modification and drug delivery solutions to medical device companies, the Surveil DCB will be the first complete vascular medical device developed and tested clinically by SurModics.

U.S. medical device companies commonly conduct clinical trials abroad to expedite time to market. To encourage medical device innovation in the United States, in 2013 the FDA introduced new guidelines under the early feasibility study program to facilitate the early clinical evaluation of medical devices in small numbers of human subjects. The guidelines allow companies to collect data on product efficacy and safety before finalization of product design while still adhering to exacting human subject protections.

“Some may see SurModics’ decision to initiate human trials on their drug-coated balloon in the United States as a bold move,” said Renu Virmani, M.D., president and medical director of CVPath Institute. CVPath has performed the histopathological assessment of all pre-clinical studies involving the Surveil DCB since the inception of the program. “Those of us who have followed the development of this product are confident in its potential given its performance in pre-clinical studies.”