7. 80 Year Olds CAN Safely Undergo Spine Surgery
A study led by Jeff Rihn, M.D., an orthopedic surgeon at the Rothman Institute, found that patients 80 and older can derive significant benefit from surgical treatment for lumbar spinal stenosis with and without degenerative spondylolisthesis. And the bonus? These patients had no higher overall complication rate and no higher mortality when compared to patients younger than age 80.
Rihn and his researchers reviewed Spine Patient Outcomes Research Trial (SPORT) data and published the results in The Journal of Bone & Joint Surgery.
Rihn said it was somewhat surprising that there was not a higher complication rate in this patient population given their advanced age and greater baseline medical comorbidities. “This finding, however, suggests that surgery can be a relatively safe option for treating these conditions in this patient population.”
6. Lessons of Whistleblowers
Two stories stood out in 2017.
The first goes all the way back to a whistleblower suit first filed in 2005 over bone stimulating devices.
A medical services consultant made the case that multiple device companies were selling osteogenesis stimulators to Medicare beneficiaries when they should have been renting them. He accused the companies of advising their physician and hospital customers on how to fill out the Medicare claims, resulting in violations of the Federal False Claims Act.
The companies eventually paid fines and settled with the government. All these cases disappeared in the rear-view mirror of the companies a long time ago, but our readers continue to revisit this story for lessons to remember.
A second whistleblower case involved firing an accountant.
Patricia Katz went to work for SpineFrontier in February 2011 as a senior accountant. She was fired in March 2012. The company basically said she was too opinionated and mishandled confidential human resources information. She said she was fired because she was pushing for a better compliance program and reported her misgivings to the FDA.
Katz sent an anonymous email to the FDA to get clarification on her concerns. The FDA agreed with her and she forwarded her correspondence with the FDA to her bosses. The FDA eventually issued a public Warning Letter to the company.
The lesson here for all device makers. If you send your staff for compliance training, prepare to have a good compliance program. And if you fire them for having strong opinions about the compliance, expect to get sued.
5. DePuy Synthes Agrees to Sell ProDisc Back to VBs
Anthony, Marc and John Viscogliosi (VBs) sold the ProDisc lumbar artificial disc replacement technology to Synthes in 2003 for $350 million.
In September 2017, the brothers, through Centinel Spine, bought the technology back from DePuy Synthes for an undisclosed price.
“Centinel Spine’s acquisition of ProDisc is absolutely positive for ProDisc as well as for spinal arthroplasty in general”, said Jack Zigler, M.D., one of the principals at The Texas Back Institute and the first U.S. surgeon to implant ProDisc L. “The Viscogliosi Brothers were instrumental in recognizing the value of spinal arthroplasty and bringing that technology into the U.S. They have personal experience with several of the pivotal IDE studies for both cervical and lumbar arthroplasty, as well as with the benefits of non-fusion technologies.”
The technology developed by a French orthopedic surgeon, Thierry Marnay, M.D., was revolutionary at the time because it obviated the need to fuse the spine—then considered the gold standard treatment for treating disc degeneration.
ProDisc L received FDA approval in 2006. The first cervical artificial disc replacement (Prestige) was approved in July 2007.
