SANUWAVE, a company out of Suwanee, Georgia, won FDA clearance to introduce in the U.S. its dermaPACE system for treatment of diabetic foot ulcers. The system, cleared through the agency’s de novo process intended for new types of medical technologies, delivers acoustic shock waves into wound tissue in order to stimulate healing. The company refers to this effect as Pulsed Acoustic Cellular Expression (PACE).
An electrohydraulic technique is used to generate acoustic pressure waves at about 510 bar that have a fast rise time of less than 33 nanoseconds and a life cycle between 2 and 8 microseconds. These characteristics allow the sound waves to move cells and tissues a bit back and forth, creating tension and compression that promotes healing through improved perfusion, arteriogenesis, the breaking apart of bacterial nanofilms, and other processes.
More details about the two studies that led to the regulatory clearance, according to SANUWAVE:
The studies were designed as prospective, randomized, double-blind, parallel-group, sham-controlled, multi-center 24-week studies at 39 centers. A total of 336 subjects were enrolled and treated with either active dermaPACE plus conventional therapy or sham dermaPACE plus conventional therapy (a.k.a. standard of care). Conventional therapy included, but was not limited to, debridement, saline-moistened gauze, and pressure reducing footwear. The objective of the studies was to compare the safety and efficacy of the dermaPACE System to sham-control application. The prospectively defined primary efficacy endpoint for the dermaPACE System studies was the incidence of complete wound closure at 12 weeks post-initial application of the dermaPACE system (active or sham). Complete wound closure was defined as complete skin re-epithelialization without drainage or dressing requirements, confirmed over two consecutive visits within 12-weeks. If the wound was considered closed for the first time at the 12-week visit, then the next visit was used to confirm closure. Investigators continued to follow subjects and evaluate wound closure through 24 weeks.
The patients who were treated with the dermaPACE System showed an increase in wound healing at 24 weeks with a 44 percent wound closure rate. Those patients treated with the sham shock wave therapy showed a 30 percent wound closure rate during the same time period. Unlike other advanced DFU treatment modalities, the dermaPACE protocol did not allow any form of closure by secondary intent (e.g. sutures). The wound closures in the dermaPACE arm were robust with less than 10% rates of recurrence. In addition, the rate of wound area reduction in the dermaPACE cohort was significant compared to that of the Sham arm beginning at six weeks and continuing on through the remainder of the 24 treatment and follow-up phases.