Becker's ASC Review

November/December Issue of Becker's ASC Review

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37 ORTHOPEDICS Stryker CEO Kevin Lobo: The hospital OR is no longer 'the center of our universe' By Angie Stewart D uring the Virtual MedTech Conference hosted by AdvaMed Oct. 5-7, medical device industry leaders reflected on how COV- ID-19 has affected healthcare volumes and reshaped future strategy. ree insights from panelists, as reported by Medical Device and Diagnostic Industry: 1. Bill Hawkins, retired CEO of Medtronic and chair of the board at Duke University Hospital in Durham, N.C.: "Honestly, I would not have expected things to have rebounded as quickly as they have, but we [at Duke University Hospital] are about 102 per- cent of prior year volume. A number of those cases are backlog... We had about 7,000 cases backlogged due to COVID-19. At the same time, with the amount of new cases coming in, we think that by the end of October/November timeframe, we could be back to 100 percent of where we were pre-COVID-19." 2. Tom Polen, president and CEO of BD: "Exit- ing June, we saw interventional procedures at 80 percent. In July, we saw that go up to 85 percent, and you could see that vary by acuity of the procedure." Hernia surgery and peripheral vascular disease procedures were among the procedures with more robust volumes, while screening-based procedure volumes have been lower, Mr. Polen added. 3. Kevin Lobo, CEO of Stryker: "We're tracking north of 80 percent [of 2019 levels]" for procedure volumes in the spine surgery realm. "ere is a monumental shi that will occur over the next decade of procedures moving out of the hospital toward surgery centers. is is already a movement that had started prior to the pandemic, and it's just accelerating tremendously. "... We've had to change our company. e center of our universe was the hospital operating room, and you cannot show up the same way to a surgery center with 22 sales reps all calling on the surgery center. ey're not able to receive that. I think the medtech companies that are in the hospital OR as the center of gravity have to change their approach and really have a different offense for their surgery centers. It's a big change for us." n FDA warns stem cell clinic about marketing claims, unapproved uses By Alan Condon A Wisconsin stem cell clinic has been cautioned by the FDA for marketing intrathecal and intravenous injections of human stem cell and tissue-based products for a variety of neurologic conditions, according to the Regulatory Affairs Professionals Society. The FDA's Center for Biologics Evaluation and Research on Oct. 1 sent a warning letter to Michael Johnson, DC, a neurologic chiropractor who runs Optimal Health Stem Cell and Wellness Institute in Appleton, Wis. The letter cited claims on the practice's website, Facebook and You- Tube channel, which marketed stem cell-based products derived from human adipose tissue, amniotic membrane and the umbilical cord. According to the practice's website, conditions treated range from Par- kinson's disease to multiple sclerosis and traumatic brain injuries. The FDA has not approved any stem cell products for orthopedic, neuro- logical or cardiovascular conditions yet. One recent Facebook post said, "we use intrathecal injections into the spine with chronic neurological patients," and claimed that hav- ing "stem cells cross the blood-brain barrier helps the neurological patient to heal faster," according to RAPS. The lawful marketing of these products requires a biologics license, which the FDA said the practice does not have. The letter added that "such unapproved uses raise potential sig- nificant safety concerns," with the methods used by the practice to administer the products another safety issue due to the "range of adverse events" that can arise from contaminated products injected intrathecally or intravenously. While there is a lot of hype about the impact of stem cell-based prod- ucts in neurology and orthopedics, there remains a significant lack of evidence, with many physicians calling for increased regulation and guidance in how these products are marketed. n NASS welcomes Dr. Eeric Truumees as president By Alan Condon T he North American Spine Society has named Eeric Truumees, MD, president during its 35th annual meeting, taking place virtually Oct. 6-9. Dr. Truumees practices with Texas Spine and Scoliosis and is professor of orthopedic and neurological surgery at the University of Texas - Dell Medical School, both in Austin. He specializes in complex, cervical spine reconstruction and spinal trauma surgery, with research interests including interdisciplinary spine care programs, outcomes analysis and spinal biomechanics. As president, Dr. Truumees has pledged to expand the society's online educational initiatives, strengthen its ties to other societies and con- tinue to support advocacy efforts. n

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