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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.

Exofin Fusion Redesign Receives FDA Approval

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.

Exofin fusion combines a self-adhering flexible mesh strip and a fast-curing 2-octyl cyanoacrylate topical adhesive to close and seal incisions while forming an immediate microbial barrier to protect against infections. Chemence Medical made strategic updates to the product by reshaping the mesh strip and relocating the initiator after observing the common complaints found in the FDA MAUDE database.

The product line now features mesh that has curved ends so that when force is applied to the area where the mesh has been applied, it is more evenly distributed along the mesh itself instead of in the four corners of the rectangular designed products. The new shape has reduced the area for potential damage due to stress by 67%.

In addition to this design change, the chemical used to aid in the cure of the adhesive was removed from the mesh and relocated within the adhesive design. This change reduces the amount of exposure the patient has to that initiator chemical by over 60%.

The company has been made aware of almost no negative patient outcomes since these changes were made to the device.

Exofin fusion is offered in three sizes: the traditional sizes of 22cm and 60cm, and now a new 30cm size, which was added in order to cover most orthopedic incisions where a 22cm is not long enough. The new size eliminates the need to open two products, a benefit that saves money for both the health care provider and the patient.

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