Device company SurModics, Inc., has received FDA Investigational Device Exemption (IDE) approval to start a first-in-human early feasibility study using the company’s SurVeil™ drug-coated balloon (DCB).
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. Doing this in a controlled and optimised manner is a challenge for device manufacturers. 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 SurVeil DCB design incorporates 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.
The company says this balloon represents 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.
The FDA IDE approval allows the company to take the steps required to start an early feasibility clinical trial. The company has identified its clinical investigators and is developing plans for up to three clinical sites in the U.S. and expects to enroll the first patient in the second quarter of fiscal 2016.
“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.”
“We are excited to have reached this milestone for the SurVeil DCB. Our decision to conduct the early feasibility study in the U.S. 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.”
Source: Business Wire