FDA, Cardinal Health Assess Scope of Potential Contamination Risk

Dr. Jeffrey E. Shuren MD, JD, Director - CDRH Offices: Office of the Center Director, released the following statement on Thursday (January 16, 2020): “On Jan. 11 and again on Jan. 15, 2020, medical device manufacturer Cardinal Health alerted its customers to...

U.S Health System Uses Medtronic Stealth Autoguide Cranial Robotic Guidance Platform

Phoenix Children’s Hospital is the first-ever health system in the U.S. to receive and deploy the newly FDA-cleared Medtronic Stealth Autoguide platform.

Cook Medical TriForce Peripheral Crossing Set Now Available

Cook Medical’s TriForce® Peripheral Crossing Set is now commercially available. As of January 2020, these products are available to physicians in the United States to support procedures to treat patients with vascular obstructions.

PENTAX Medical Launches IMAGINA Endoscopy System in U.S.

IMAGINA offers practitioners a modern user interface and unique endoscope design to provide excellent visualization, improve the operator experience and positively influence long-term patient care costs.

KCI Expands Surgical Portfolio with Launch of PREVENA RESTOR BELLA•FORM™ Incision Management System at Plastic Surgery The Meeting

SAN ANTONIO–(BUSINESS WIRE)–KCI, an Acelity Company, today announced the availability of PREVENA RESTOR BELLA•FORM™ System, specifically designed to manage post-operative incisions, as well as the surrounding soft tissue envelope following surgical procedures, to stabilize the incision and surrounding surgical area, reduce edema and help improve healing. This launch is the first of the PREVENA RESTOR™ Therapy offering, a new portfolio that further optimizes post-surgical care and expands the Company’s surgical offerings.

“With the introduction of the PREVENA RESTOR BELLA•FORM™ System, we are advancing how surgeons can care for patients recovering from surgery, such as reconstructive soft tissue procedures. This first-to-market therapy was built specifically with the patient’s recovery journey in mind,” said R. Andrew Eckert, Chief Executive Officer, KCI. “The PREVENA RESTOR BELLA•FORM™ System addresses a significant clinical need by reimagining the traditional applications of negative pressure and thinking beyond the incision to help support improved healing in aspirational ways—all backed by the undisputed outcomes of PREVENA™ Therapy.”

“Particularly, when it comes to reconstructive procedures, clinicians and patients are dealing with a variety of challenges that are unavoidable because of the nature of the procedure, including compromised blood flow and tissue loss,” said Ronald Silverman, MD, FACS, Chief Medical Officer, KCI. “With the PREVENA RESTOR BELLA•FORM™ System, clinicians are able to not only protect the incisions against external contaminants, but they are also able to stabilize the incision and surrounding surgical area, with the goal of lowering the risk of surgical site complications. This may lead to better outcomes and help health care providers discharge their patients with confidence.”

The PREVENA RESTOR BELLA•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 7 days);
  • Expanded coverage area: dressing seamlessly conforms to patient;
  • Precision design: larger dressing delivers therapy to incision and surrounding soft tissue envelope;
  • Stabilize the reconstruction: mechanically stabilize the incision and surrounding soft tissue;
  • Easy to apply: peel and place the form-fitting dressing

“As a plastic surgeon that specializes in breast reconstruction, I know that these types of surgeries can be incredibly complex. Not only do you run the risk of surgical site complications, but you also see patients whose breast compartment can collapse, further complicating an already emotional surgery,” said Allen Gabriel, MD, FACS. “I want my patients to have positive clinical outcomes, and also to be happy with their results, helping restore their sense of self after a life-altering diagnosis and surgery. With the introduction of the PREVENA RESTOR BELLA•FORM™ System, I can take my post-operative care one step further by offering patients a therapy that protects the incision and helps manage the environment, putting my patients at ease during their recovery.”

In a 2018 report, the American Society of Plastic Surgeons (ASPS) stated that there were more than 5.8 million reconstructive plastic surgery procedures in the United States.1

The PREVENA RESTOR BELLA•FORM™ System will be on display at booth #1435 during Plastic Surgery The Meeting, September 20-23, 2019, at the San Diego Convention Center.



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