Activ Surgical Announces FDA Clearance for ActivSight Intraoperative Imaging Module

Activ Surgical announced the U.S. Food and Drug Administration (FDA) 510(k) clearance of the company’s ActivSight Intraoperative Imaging Module for enhanced surgical visualization.

Metrex Surface Disinfectant Portfolio Secures EPA Approval

The U.S. Environmental Protection Agency (EPA) has approved all eight surface disinfectant products made by an infection prevention leader, Metrex, as effective against SARS-CoV-2, the novel coronavirus that causes COVID-19.

Olympus Supports Safety Actions Regarding Surgical Smoke

Olympus has announced its support of The Joint Commission’s recommended safety actions for managing the hazards of exposure to surgical smoke for health care staff in operating rooms.

Exofin Fusion Redesign Receives FDA Approval

Chemence Medical, a leader in medical cyanoacrylate devices and products, announced the U.S. Federal Drug Administration’s (FDA) 510(k) approval of the company’s redesigned exofin fusion skin closure system.

3M Expands Surgical Portfolio


3M has announced the availability of PREVENA RESTOR AXIO•FORM Incision Management System, designed to manage post-operative incisions, as well as the surrounding soft tissue envelope, following the orthopedic surgical repair of lower extremity fractures. Prevena Restor Axio•Form helps stabilize the incision and surrounding soft tissue, reduce edema, and help enhance post-operative recovery. This is the third offering in the Prevena Restor Therapy portfolio, launched in 2019, to optimize post-surgical care and expand the company’s specialty surgical offerings.

“Patients recovering from lower extremity fractures often experience complications which can potentially compromise the healing process, leading to delayed rehabilitation and poor functional outcomes,” said Dr. Brett D. Crist, MD, FAAOS, FACS, FAOA, director of orthopaedic surgery, University of Missouri School of Medicine, who participated in the pre-market pilot. “The Prevena Restor Axio•Form System provides a unique solution for post-surgical incision and soft tissue envelope management for the lower extremity – which can be one of the most complex and challenging anatomical areas. The expanded coverage and precision design lend themselves to better conformity on the surgical site, providing us confidence for our patients’ recovery.”

The Prevena Restor Axio•Form System encompasses the same proven technology as the Prevena Incision Management System, with added benefits including:

  • Extended therapy time: up to 14 days (dressing change required after seven days);
  • Expanded coverage area: dressing seamlessly conforms to the patient;
  • Precision design: larger dressing delivers therapy to incision and surrounding soft tissue envelope;
  • Mechanically stabilize the incision and surrounding soft tissue;
  • Easy to apply, form-fitting Peel & Place dressing

“Not all surgical incisions are the same size, and orthopedic fracture repairs can be complex, which is why we offer clinicians a variety of products to accommodate their individual patient’s needs,” said Ronald Silverman, MD, FACS, chief medical officer, 3M. “Given the current pandemic, it is even more critical to minimize the length of hospital stays for patients and, once they return home, lessen the number of in-person visits during recovery. Prevena Restor Axio•Form System aims to get patients home quickly and safely post-surgery, which is a priority now more than ever.”

The system was made commercially available in August 2020. Information on the system is available on the American Orthopedic Foot & Ankle Society (AOFAS) and Orthopedic Trauma Association (OTA) annual conference websites.



Submit a Comment

Your email address will not be published. Required fields are marked *