Common sense would hold that surgeons fix torn tissue, rather than making it worse. But that's exactly what happens when orthopedists endeavor to fix partial articular sided tendon avulsion (PASTA) tears – a type of rotator cuff tear that commonly causes shoulder pain.
The remaining attached supraspinatus tendon is usually fully torn from its natural position and then reattached.
"When it's 50% torn, the clinician tears the rest away in order to repair it," Tate Scott, chairman/CEO of KFx Medical (Carlsbad, California), told Medical Device Daily. "As you can imagine, clinicians don't like to tear away good tissue. But it's a degenerative disease and they know what the end of the story is. It's going to go on to become a full-thickness tear eventually; most do."
KFx has just launched PASTAFx Anchor System, which is designed to repair partial rotator cuff tears, avoiding the need to fully tear the tendon first.
"The PASTAFx system enables you to put the anchor through the tendon and then into bone without removing the tendon," Scott said. "That's why it's different. It makes the doctor more comfortable with repairing early because they don't have to tear the tendon."
Surgeons have been using anchors to do repairs for decades. But the problem with most anchors comes down to size. Most are about 4 mm.
"If you screw that through the tendon, you've just further denigrated the tendon," he said. "Yet if they don't remove the tendon to repair it, then they can't get a big enough anchor in place to be worthwhile. Our system goes in through the tendon at 3 mm. Once it's under the bone, it expands to a 10 mm wingspan."
Picture a hollow-wall expanding anchors, such as a molly bolt or toggle screw, and you get the idea.
"We saw the need for this product and we believe PASTAFx will become a new standard of care," Scott said.
FDA 510(k) clearance for PASTAFx was obtained several years ago, but the company has made some modification so that it's more user-friendly before commercially launching the product this month.
PASTAFx will be the second flagship product for this small company. The first, SutureCross Knotless Fixation System, is used for arthroscopic, double-row rotator cuff and some PASTA repairs.
Privately held KFx is venture-backed. Investors include Alloy Ventures, Charter Life Sciences, Arboretum Ventures, Montreux Equity Partners, and MB Venture Partners.
For now, it intends to produce PASTAFx independently.
"We manufacture it ourselves in Carlsbad," Scott said. "Our focus and dream here is true treatment of disease states. We're not a product company. We're a procedures company."
He added, "We're sufficiently funded and we've got a great team of venture investors; we follow a capital-efficient model. We're not a company built on putting 60 direct sales people in the field. We are focused on disease states and proving, with good clinical results, that we can manage that," he said.
With about 400,000 rotator cuff injuries reported each year in the U.S., the company has a fairly broad market to address. Just back from the American Academy of Orthopaedic Surgeons (Rosemont, Illinois) meeting in Las Vegas, Tate said the launch of PASTAFx went well.
"You always feel like you've done things right when clinicians take a look and say 'Gosh, I've been searching for a product for PASTAs' and you identify an unmet need," he said. "They really light up, because their goal is to do right by their patients."
Jonathan Ticker, MD, an assistant clinical professor of orthopaedic surgery at Columbia University's College of Physicians and Surgeons (New York), commented on the PASTAFx approach.
"As surgeons, we are conflicted with these types of tears. On the one hand, we are trained to preserve healthy tissue; however, we know the likely outcomes of this progressive disease once it begins," Ticker said. "I am seeing a growing body of literature advocating the trend toward earlier intervention to remediate PASTA lesions given the natural progression of rotator cuff disease."
He added, "The KFx PASTAFx is a valuable tool in the arsenal of shoulder surgeons to preserve healthy tissue and achieve optimal outcomes regardless of what kind of tears are encountered in rotator cuff pathology."