FDA Says JustRight Surgical® 5mm Classic Surgical Stapler is… Just Right (Sorry)

In case you’d not come across the company before (we hadn’t), JustRight Surgical describes itself as a micro-laparoscopic medical device company devoted to miniaturizing surgical instrumentation. Now it has received FDA 510(k) clearance for its JustRight™ 5mm Stapler.

Background

JustRight’s stapler, the smallest classic stapler on the market, is intended for use by surgeons in pediatric and general surgery where access is limited and visibility is reduced. The company claims this is a major step forward for the pediatric surgical community in particular as options configured specifically for pediatric surgery have hitherto been limited.

Since 1972, when pediatric surgery became a recognized subspecialty, JustRight tells us surgeons have been asking companies to miniaturize instrumentation to better serve infants and children requiring surgery. That’s a nut the company clearly intends to crack, the newly cleared device being 9 times smaller than existing stapling instruments, yet still delivering the security of the gold standard “B” staple formation. The stapler’s 5mm shaft means it can be delivered into the tightest of spots and other features include a single motion stapling and cutting action, optimised jaw length and 360 degree jaw rotation.

Physician comments

“The needs of our smallest patients are unique, yet the surgical tools available to surgeons for these cases are virtually non-existent,” said Dr. Steve Rothenberg, medical advisor and co-founder of JustRight Surgical. “In the electronics industry, miniaturization happens almost faster than we can absorb the changes. Meanwhile, the downsizing of surgical instrumentation has remained stagnant and we have made it our mission to change that.”

Company comments

“The absence of innovation in this market is primarily due to minimal financial incentives for large companies to develop these micro instruments,” said Russ Lindemann, president and CEO of JustRight Surgical. “As a result, pediatric surgeons are forced to use devices originally designed for adults. These instruments can be oversized, overpowered and difficult to maneuver in small patients and tight spaces. We felt it was critical to answer the call for smaller devices and expand the options available.”

Source: JustRight Surgical, Inc., PR Newswire

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