Now, the Rest of the Story
If John Sherman and Scott Blumenthal thought that this was the end of their annular repair journey—they were about to be find out differently in Berlin.
At a spine meeting in Berlin, Germany, in October 2017, John Sherman was cruising the exhibit hall when he noticed a table with devices that looked suspiciously like annular repair instruments.
Sherman asked a company representative standing at the table if the FDA had cleared these devices. The answer was…wait for it…”YES.”
“Of course, you could have pushed me over with a feather,” Sherman told OTW.
The company Sherman was talking to was a Canadian firm named Anchor Orthopedics XT, Inc., located in Mississauga, Canada.
As Blumenthal explains, “Anchor is permitted to market these closure devices for disc repair, but not for annular repair. It was a fascinating kind of thing and I had the same reaction as John did. What do you mean you were approved for this?”
Disc Repair
Both Sherman and Blumenthal ended up meeting with representatives from the company at their headquarters to learn more about their product.
“The best I could gather from when we met with them, they just had better FDA consultants and a better law firm to get the labeling in the U.S.,” Blumenthal said.
On the future of annular repair, Blumenthal said that while Anulex’s Xclose system worked and was easy to use, surgeons are not going to want to revisit a medical device that has already come and gone.
Anchor is new to the U.S. and is just now getting its marketing and sales effort launched. As Blumenthal explained to OTW, Anchor is developing a marketing and sales team in the U.S. that can reach the people who are doing the microdiscectomies. “When I first met Anchor Orthopedics, they had their own sales team but none of them knew the surgeons in the market, so they had to make cold calls. So, they are starting to develop connections with distributors that have relationships with spine surgeons.”
And, a lot has changed since Xclose received its 510(k) in 2006. The rise of the Ambulatory Surgery Center (ASC) has changed the minimally invasive surgery (MIS) and microdiscectomy market which, in turn, will influence Anchor’s disc repair product—particularly with regards to reimbursement.
Reimbursement.
Like the FDA in a fun house.
