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Home » Baxter wins FDA nod for next-gen staple-line reinforcements

Baxter wins FDA nod for next-gen staple-line reinforcements

February 27, 2020 By Sean Whooley

Baxter (NYSE:BAX) announced today that it received FDA 510(k) clearance for the new generation of its Peri-Strips Dry with Veritas collagen matrix (PSDV) staple-line reinforcement material.

The “PSDV with secure grip” is now available with peel-and-secure technology. Baxter touts the new generation of the product as two times faster in preparation when compared to the previous version.

Baxter’s PSDV with secure grip is applied to the surgical stapler with a pressure-sensitive adhesive strip, allowing surgeons to easily manipulate tissue. The company said that a recent study showed that 30 bariatric nurses and surgical technicians unanimously chose PSDV with secure grip over other options after comparing them in preparation time, ease of use and learnability in the operating room.

According to a news release, PSDV is proven to effectively reduce intraoperative and postoperative staple line bleeds and leaks in routine bariatric procedures, such as sleeve gastrectomy or gastric bypass.

“We continue to advance innovation by providing surgeons tools that are faster and easier to use in the operating room,” Baxter advanced surgery business president Wil Boren said in the news release. “As surgical procedures are becoming more complex, it is important that surgeons have the tools they need to optimize patient care.”

Filed Under: 510(k), Food & Drug Administration (FDA), Regulatory/Compliance, Surgical, Weight loss Tagged With: Baxter, FDA

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About Sean Whooley

Sean Whooley is an associate editor who mainly produces work for MassDevice, Medical Design & Outsourcing and Drug Delivery Business News. He received a bachelor's degree in multiplatform journalism from the University of Maryland, College Park. You can connect with him on LinkedIn or email him at [email protected].

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