Winter Innovations secures FDA 510(k) clearance for EasyWhip
By Tom Ballard, Chief Alliance Officer, PYA
Less than two months after submitting its 510(k) application to the U.S. Food and Drug Administration, Winter Innovations Inc. has received clearance from the federal agency for its EasyWhipTM suturing needle device.
The announcement was made this week and, as you might imagine, the two Co-Founders are ecstatic about this significant milestone in the company’s development. For Lia Winter, Chief Executive Officer who developed the idea for the device and has pitched it at many competitions, it is the latest accomplishment in a multi-year journey that included winning at least $150,000 in those competitions.
“We are extremely pleased to have received 510(k) clearance for EasyWhipTM and believe that the ease of use and time savings benefits will be attractive for our Orthopedic Surgeon and Physician Assistant end users,” she said. Co-Founder Preston Dishner, who also serves as Chief Operating Officer, echoed her thoughts.
“The speed at which we were able to navigate this regulatory hurdle is a testament to the strong team and ecosystem that we have supporting us,” he said. “Our focus now is on ramping up production and preparing for limited market release. We are excited to deliver a new and innovative suturing system that can raise the operating efficiency for hospital and surgery center customers.”
EasyWhipTM is a non-absorbable suture with a specialized needle that simplifies and standardizes suturing techniques. Its primary application is for orthopedic procedures to repair torn ligaments and tendons, like the anterior cruciate ligament (ACL), Achilles’ tendon, and distal biceps tendon.
As explained by Winter, the innovation in EasyWhipTM is the patented two-part needle, which has a needle tip and a connectable rod/insert. The two needle components are fixed to ends of a length of ultra-high strength orthopedic suture. They can be connected to create a continuous loop of suture and disconnected to create a straight length of suture, which facilitates faster, easier stitching and creation of patterns that cannot be made with conventional needles.
Winter earned her undergraduate degree at the University of Pittsburgh, and one of the early professionals with whom she engaged was James Bradley, MD, an Orthopedic Surgeon in Pittsburgh who is also the team physician for the Pittsburgh Steelers.
“The beauty of EasyWhipTM is that it’s sophisticated, yet so simple,” Bradley said, adding, “And it’s reproducible. Because of its configuration, there are three or four different stitch patterns that you can make with EasyWhipTM. Timing-wise, I’m much faster with this product than I am using a traditional whip stitch needle.”
As reported a couple of weeks ago in teknovation.biz, Winter Innovations also recently announced that it received a $256,000 Small Business Innovation Research grant from the National Science Foundation. This funding will allow the start-up to perform research and development on the two-part needle technology for orthopedic applications and provide a basis for additional research for other surgical applications.
EasyWhipTM is the first FDA-cleared product for Winter Innovations. It is indicated for use in approximation and/or ligation of soft tissues, including the use of allograft tissue for orthopedic surgeries.
