Baxter International Gets FDA Nod For PSDV With Secure Grip

Baxter International has secured 510(k) clearance from the US Food and Drug Administration (FDA) for its new-generation Peri-Strips Dry with Veritas Collagen Matrix (PSDV) product, dubbed as PSDV with Secure Grip.

The PSDV, which is now added with peel and secure technology, is a staple line reinforcement material that has been helping bariatric surgeons to address staple line complications for over 15 years.

The new generation of PSDV is two times faster to prepare compared against an earlier version

According to the company, the new generation of PSDV is two times faster to prepare compared to the earlier version and another staple line reinforcement product.

The PSDV is said to minimise intraoperative and postoperative staple line bleeds and leaks in routine bariatric procedures such as a sleeve gastrectomy or gastric bypass.

A 2015 meta-analysis analysis extracted data from 295 studies included morbidly obese patients undergoing laparoscopic gastric bypass and laparoscopic sleeve gastrectomy. The procedures involved around 42,000 patients concerning bleeds and over 56,000 patients concerning leaks.

The PSDV demonstrated statistically significant relative efficacy in reducing bleeding and leaks compared against staple line reinforcement, oversewing, and another staple line reinforcement product.

Baxter’s PSDV with Secure Grip is applied to the surgical stapler through a pressure-sensitive adhesive strip.  The new generation of PSDV offers betters adherence to the stapler, enabling surgeons to easily manipulate tissue.

Baxter’s advanced surgery business president Wil Boren said: “We continue to advance innovation by providing surgeons tools that are faster and easier to use in the operating room.

“As surgical procedures are becoming more complex, it is important that surgeons have the tools they need to optimize patient care.”

Recently, Baxter secured FDA approval for its metabolic monitoring device Q-NRG+, which leverages indirect calorimetry (IC) technology, which is considered as gold standard for precise measurement of resting energy expenditure (REE).-NS Medical Devices