FDA Approves IDE for SurModics' Early Feasibility Study of SurVeil DCB

October 5, 2015—SurModics, Inc. announced that it has received approval for an investigational device exemption from the US Food and Drug Administration to conduct its first-in-human early feasibility study of the SurModics SurVeil drug-coated balloon (DCB). The company has identified its clinical investigators and is developing plans for up to three clinical sites in the United States. Enrollment of the first patient is expected to begin in the second quarter of fiscal year 2016.

The SurVeil DCB design incorporates SurModics’ drug excipient formulation for the balloon coating and a new manufacturing process for the coating applications. It also includes the SurModics Serene low-friction, low-particulate hydrophilic coating on the catheter shaft. The SurVeil DCB is not available for sale in the United States and is for investigational use only, advised the company.

In SurModics' press release, Kenneth Rosenfield, MD, commented,  “While the utilization of DCB therapy is growing rapidly and the clinical results for patients with lower extremity peripheral artery disease are very encouraging, there are real opportunities to improve upon the early-generation DCB technologies that are currently available. 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.” Dr. Rosenfield, who serves as Chair of the SurModics Clinical Advisory Board, is Section Head of Vascular Medicine and Intervention at Massachusetts General Hospital in Boston, Massachusetts.

Renu Virmani, MD, added, “Some may see SurModics’ decision to initiate human trials on their DCB in the United States as a bold move. Those of us who have followed the development of this product are confident in its potential given its performance in preclinical studies.” Dr. Virmani is President and Medical Director of CVPath Institute, which has performed the histopathological assessment of all preclinical studies involving the SurVeil DCB since the inception of the program.