FDA clears battery-free suction pump for surgical wound closures

The FDA cleared a miniaturized device designed to help heal open wounds after surgery by sealing and holding them shut using gentle suction. 

Aatru Medical’s offering differs from typical negative pressure wound therapy equipment—which usually relies on larger electric air pumps, batteries and nozzles—using a small, single-use device that operates silently.

With a clearance in hand and manufacturing partners lined up, the company now plans to commercially launch its device in multiple countries, according to a statement from CEO Timothy Wojciechowski.

Aatru’s NPSIMS—short for negative pressure surgical incision management system—includes slim peel-and-stick dressings in different sizes that adhere over the wound. Connected by a small hose, the disposable, three-ounce device is powered by a solid-state, chemical pump that traps air within it to provide suction for as long as seven days.

Wound complications are common after surgery, with about half-a-million incision site infections reported annually in the U.S., leading to about 8,000 deaths, according to the company. Applying suction through a dressing can help pull out bodily fluids while holding the skin together as it heals when used in addition to typical closure methods such as sutures.

These infections are also a leading cause of hospital costs, making up about a fifth of all readmissions following a procedure.

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The Cleveland-based Aatru estimates that the global closed surgical incision market tops about $12 billion annually—and that with modifications to its stick-on dressings and an additional FDA clearance, its NPSIMS device could be adapted for the similarly large chronic wound market as well.

Companies with wound care portfolios such as Smith & Nephew have also sought to miniaturize their negative pressure devices and move away from bulky air pumps. The company’s single-use Pico 7 can be clipped to a belt and operates on two AA batteries.

Aatru submitted its NPSIMS device to the FDA in July 2020, alongside the closure of a series C venture capital funding round of an undisclosed amount.