FDA Clears Via Surgical’s Suture-Based Fixation System

Israeli-based Via Surgical has received FDA 510(k) clearance for the company's TissueTak™ tendon anchor. The company says it's the first suture-based fixation system to be used for arthroscopic rotator cuff repair and augmentation.

Brian J. Cole, M.D., Professor in the Department of Orthopedics at Rush University Medical Center in Chicago, said the anchor is "very easy to use" in arthroscopic surgeries. "We are always striving to improve the clinical outcomes of our patients following rotator cuff repair and technically we have not had a reliable solution to augment these repairs with a patch due to the absence of proper fixation options. The TissueTak is the first commercially available option to provide efficient mechanical fixation of a patch to the native rotator cuff tissue. Considering the fact that there are almost half a million of these procedures done each year in the U.S. alone, TissueTak holds amazing potential in the field of orthopedics.”

The device was cleared back in January, but the company didn't announce the clearance until July. The company says the delay was due to a confidentiality agreement with Arthrex, Inc. TissueTak is a trademark owned by Arthrex.

The FDA clearance documents state the anchor is intended for "fixation of prosthetic or biologic material to soft tissues in various minimally invasive and open surgical procedures such as hernia or rotator cuff repairs."

Device Description

The device, described as an implantable staple by the documents, is a disposable, sterile single-use system designed to deliver absorbable fastener into tissue and prosthesis during general surgery procedures such as hernia or rotator cuff repairs. It is designed to be inserted through a 5mm or larger laparoscopic port sleeve.

The fasteners two ends are designed to be locked together in the tissue by a firing mechanism, "thus forming a closed locked loop into the tissue affixing the surgical mesh/patch to the tissue." The fasteners are absorbable.

The only change a previously cleared fixation system from the company, includes a clarification of the intended use wording to include rotator cuff repair.

The company notes that rotator cuff tears are one of the most common sports injuries and often require surgery to repair the damaged torn tendon to bone. "Recent innovations," according to the company, "involving biological augmentation, where a graft is affixed to supplement the injured tendon, require a surgical staple or complex suturing techniques."

Via Surgical has three FDA clearances, 17 issued patents in the U.S. and worldwide, and 17 additional provisional patents filed in the U.S. The fixation system, according to the company, was voted as one of the Top 10 Surgical Solutions by MedTech Outlook Review. The company also received the Seal of Excellence from Horizon 2020, the EU’s research and innovation funding program.

The company was founded in 2012, with a track record in the hernia space. The company is backed by $6 million in funding.