Baxter International has announced 510(k) clearance from the FDA for a new generation of its Peri-Strips Dry with Veritas Collagen Matrix (PSDV) product, with Secure Grip. Now available with ’peel and secure’ technology, PSDV is a staple line reinforcement material that bariatric surgeons have used to mitigate staple line complications for more than 15 years. According to the company, this new generation of PSDV is two times faster to prepare compared to the previous version and another staple line reinforcement product (1).
Despite the sophistication of modern stapling technology used in bariatric procedures, staple line complications that result in high morbidity and mortality persist. The most prevalent complications are staple line bleeding and leaks. While the incidence of these complications is low, the impact can be clinically debilitating for the patient and costly to address (2).
PSDV with Secure Grip is applied to the surgical stapler via a pressure-sensitive adhesive strip. The new generation of PSDV provides strong adherence to the stapler, allowing surgeons to easily manipulate tissue. In a recent Staple Line Reinforcement Comparison study1, 30 bariatric nurses and surgical technicians evaluated stapler preparation time, ease of use and learnability of the PSDV with Secure Grip versus other options. Participants unanimously chose PSDV with Secure Grip as the most preferred staple line reinforcement material in the operating room.
“We continue to advance innovation by providing surgeons tools that are faster and easier to use in the operating room,” said Wil Boren, president of Baxter’s Advanced Surgery business. “As surgical procedures are becoming more complex, it is important that surgeons have the tools they need to optimise patient care.”
PSDV is proven to effectively reduce intraoperative and postoperative staple line bleeds and leaks in routine bariatric procedures such as a sleeve gastrectomy or gastric bypass. A 2015 meta-analysis extracted data from 295 studies predominantly comprised of morbidly obese patients undergoing laparoscopic gastric bypass and laparoscopic sleeve gastrectomy to include nearly 42,000 patients concerning bleeds and over 56,000 patients concerning leaks. PSDV showed statistically significant greater relative efficacy in reducing bleeding and leaks when compared to no staple line reinforcement, oversewing, and another staple line reinforcement product (2).
References
Baxter data on file. Staple Line Reinforcement Comparison Study with PSDV Secure Grip, PSDV Gel, and SEAMGUARD
Shikora SA, Mahoney CB. Clinical Benefit of Gastric Staple Line Reinforcement (SLR) in Gastrointestinal Surgery: a Meta-analysis. Obes Surg. 2015 Jul;25(7):1133-41. This study was supported by a grant from Baxter.