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Tuesday, Apr 23, 2024

Local Spine Clinic Studies Artificial Disc Expansion

A Newport Beach spine surgery center is taking part in a clinical study to determine an expansion in the use of cervical artificial discs.

The Disc Surgery Center is now enrolling patients for the safety and effectiveness of the Orthofix Medical Inc.’s M6-C artificial cervical disc for what’s called a “two-level” replacement.

It’s enrolling candidates between the ages of 18 and 75 who need neck surgery for the treatment of neck and arm pain or spinal cord compression.­­­

Drs. Ali Mesiwala and Grant Shifflett are joining other spine surgeons who are conducting the surgeries at about 30 clinical sites across the country.

The Disc Surgery Center has already implanted some 1,600 artificial discs since 2018. The Orthofix M6-C artificial cervical disc is already approved by the Food and Drug Administration for single-level surgical procedures.

Now, Orthofix wants to take it a step further by studying patients with what is known as two-level symptomatic cervical radiculopathy with or without cord compression.

The difference is that in a single level, only one abnormal disc is addressed. If the patient has more than one disc that is causing problems, then a two-level operation is needed.

“Any medical device sold in the United States to treat this disease, specifically an artificial disc, must show that it is at least as good, if not better, than a traditional fusion for two-level disc disease,” Mesiwala said in an email.

“This trial is addressing the two-level disc problems and what can be safely treated using the Orthofix device.”

Orthofix (Nasdaq: OFIX) is the world’s eighth-largest orthopedic medical device maker with spine and orthopedic products that are sold in 68 countries worldwide. The Lewisville, Texas-based company, which has a $489 million market cap, was expected by analysts to report $742 million in sales last year.

The company has a 70,000-square-foot base in Irvine, used to make biologics products.

Hypothesis Fun

Results will be compared with patients receiving anterior cervical discectomy and fusion, i.e. the traditional, gold-standard treatment.

“It’s fun to have a hypothesis on how well something will work and then go out and prove it or disprove it,” Shifflett told the Business Journal.

“No matter the outcome, we will use this data to better educate our spine surgical colleagues and ultimately our patients on the availability and success of treatment options for degenerative cervical spine pathologies.”

Shifflett is known as “the golf doctor” because he plays the sport (69 is his best score) and knows the injuries it can create. Monthly, he sees 25 to 50 patients who play golf.

“When I see a golfer and they have a problem, I can understand what they want to get back to,” he said. “If I were them, I don’t want to hear the words ‘you cannot go back to golf.’”

Dr. Robert Bray founded the Disc Surgery Center in 2006 with the goal of shortening lengthy hospital stays. Chicago Pacific Founders in 2022 acquired a majority stake and made it part of TriasMD, which is aiming to expand throughout California; last year, it opened a surgery center in Marina del Rey.

The Disc facility in Newport Beach emphasizes minimally invasive surgery where patients are encouraged to walk within a few hours after surgery. Its goal is to treat 1,000 to 1,500 spine cases annually.

The study is an indication of how quickly spinal surgery is changing, said Mesiwala, who has performed more than 12,000 operations.

“Increasingly, we are using minimally invasive technologies with smaller incisions and replacing mechanical devices with biological implants that can regenerate parts of the spine. The use of computers and robotics will change things further. The goal is to be less invasive and try to restore normal functions in the body without having to cut things out.”

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Sonia Chung
Sonia Chung
Sonia Chung joined the Orange County Business Journal in 2021 as their Marketing Creative Director. In her role she creates all visual content as it relates to the marketing needs for the sales and events teams. Her responsibilities include the creation of marketing materials for six annual corporate events, weekly print advertisements, sales flyers in correspondence to the editorial calendar, social media graphics, PowerPoint presentation decks, e-blasts, and maintains the online presence for Orange County Business Journal’s corporate events.

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