The 10 largest orthopedic device companies in the world

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Robot-assisted surgery continues to generate headlines in the orthopedics space. But there is so much more going on among the world’s largest orthopedic device companies.

Go to our sister site Medical Design & Outsourcing and discover what’s new among the 10 largest companies in the medical device industry’s ortho sector.

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Note: Medical Design & Outsourcing drew on research for its annual Big 100 list of largest medical device companies to create the 10 largest orthopedic device companies list.

 

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Orthofix Medical touts data from artificial disc study

Orthofix Medical’s M6-C artificial cervical disc (Image from Orthofix)

A study of patients implanted with Orthofix Medical’s (NSDQ:OFIX) M6-C artificial cervical disc showed a significant improvement in neck and arm pain, function and quality of life scores, the company said today.

Patients in the investigational device exemption (IDE) study also used less pain and opioid medication when compared with anterior cervical discectomy and fusion (ACDF) patients, and 92% reported they were satisfied with the surgery, the Lewisville, Texas-based business said in a prepared statement.

At 24 months, patients in the ACDF group who were still using pain medications had a seven times higher rate of opioid use than those in the M6-C disc group, the study showed. In the M6-C group, 92% reported that were satisfied with the surgery.

“The results from the M6-C artificial cervical disc IDE clinical study continue to validate the positive outcomes of cervical disc arthroplasty versus discectomy with fusion,” said Dr. Jack Zigler, an orthopedic spine surgeon at Texas Back Institute and an investigator in the study. “A significant reduction in pain, the maintenance or improvement of neurological function, and the preservation of natural disc motion after 24 months were all meaningful clinical benefits the M6-C disc patients experienced when compared to the fusion control.”

Zigler presented the study results during the International Society for the Advancement of Spine Surgery (ISASS) annual meeting in Anaheim, Calif.

A prospective, non-randomized, concurrently controlled clinical trial, the M6-C IDE study was conducted at 23 U.S. sites with an average patient age of 44 years. The study evaluated the safety and effectiveness of the M6-C artificial cervical disc compared to ACDF for the treatment of single-level symptomatic cervical radiculopathy with or without cord compression. The overall success rate for the protocol-specified primary endpoint for the M6-C disc patients was 86.8% at 24 months and 79.3% in the control group. This data statistically demonstrate that cervical disc replacement with the M6-C disc is not inferior to treatment with ACDF.

M6-C disc patients demonstrated statistically significant improvement in the Neck Disability Index as measured at week six and months three, six, 12 and 24. Before surgery, 80.6% of the M6-C disc patients and 85.7% of the ACDF patients were taking pain medication for the treatment of their cervical spine condition. At 24 months, the rate of M6-C patients still taking pain medication dropped to 14% compared to 38.2% of the ACDF patients. Of these, there was a seven times higher rate of opioid use with the ACDF patients than with patients who received the M6-C disc.

Average mean surgery time for the M6-C disc was 74.5 minutes versus 120.2 minutes for the ACDF procedure. M6-C patients also had shorter hospital stays and fewer needed follow-up surgery than ACDF patients.

The M6-C artificial cervical disc is made of ultra-high molecular weight polyethylene fiber wrapped in a specific pattern, with multiple redundant layers that create a fiber matrix (artificial annulus). The fiber is then wound around a polycarbonate urethane polymer core creating an artificial nucleus. Like a natural disc, this unique construct allows for shock absorption at the implanted level, as well as provides a controlled range of motion when the spine transitions in its combined complex movements, according to the company.

“With the recent FDA approval of the M6-C artificial cervical disc, we are excited to be able to provide spine surgeons and their patients a new and innovative alternative to the ball-and-socket artificial disc designs currently available in the U.S.,” said global president of Orthofix Spine Brad Niemann in a prepared statement. “What makes the M6-C disc so unique is its physiologic single-piece design featuring an artificial nucleus and annulus that work together to mimic the biomechanical motion of a natural disc to include axial compression or shock absorption, which no other disc available in the U.S. has to offer.”

Orthofix said it will release the M6-C disc in 2019 through a controlled, limited market launch in the U.S. accompanied by an extensive training and education curriculum for surgeons. The device CE Mark approval for distribution in the E.U. and other countries in 2006; there have been more than 45,000 implants of the M6-C artificial cervical disc outside of the U.S. to date.

J&J and its surgical orthopedic robot: What you need to know

Johnson & Johnson DePuy Synthes Orthotaxi surgical orthopedic robotJohnson & Johnson (NYSE:JNJ) isn’t known for tooting its horn prematurely. The public won’t hear much about a new J&J device until the company’s good and ready.

So it should come as no surprise that J&J’s DePuy Synthes business has kept relatively mum about the robotically assisted knee surgery device it’s been developing. J&J entered the competitive surgical orthopedic robot world when DePuy Synthes bought Paris-based Orthotaxy and its orthopedic-surgery robot prototype in 2018.

DePuy Synthes gave attendees at the recent American Academy of Orthopedic Surgeons conference a peek at the latest prototype of the Orthotaxy device. It’s is the size of a shoebox, attaches to an operating table and includes a saw, but does not do the sawing for the surgeon. Instead, the Orthotaxy platform will design the surgery plan and lock the saw into a plane, allowing the surgeon to do the cutting, according to Liam Rowley, VP of R&D for knees at DePuy.

“There are no blocks required. There’s no pinning required,” Rowley said. “We saw this as what the world actually needs. This is bed-mounted. It’s not a huge device that sits on the floor.”

Get the full story on our sister site Medical Design & Outsourcing. 

Treace Medical touts results of bunion surgery study

Treace Medical’s Lapiplasty bunion procedure is designed to correct foot bone alignment and stabilize the toe. (Image from Treace Medical)

Treace Medical Concepts said a study of its bunion implant surgery showed more rapid healing than traditional osteotomy.

The study of the Ponte Vedra, Fla.-based company’s Lapiplasty 3D bunion correction system showed that most patients were able to stand on their operative foot five days after surgery and had a high rate of healing nine months after the procedure.

The study enrolled 195 patients, including 19.5% who had comorbidities known to compromise bone healing, with a mean follow-up of 9.5 months. Ninety-seven percent of the patients demonstrated a successful bony fusion of the joint and 98.9% maintained a stable joint position over the course of the study, which was published in The Journal of Foot & Ankle Surgery. The implant removal rate was 3.1% compared with conventional plate implants where published removal rates can be greater than of 17% for tarsometatarsal and 20% for big-toe joint fusion procedures.

The Lapiplasty procedure is designed to reproducibly correct all three planes of the bunion deformity and address the root cause of the bunion while allowing patients to get back to their active lives quickly. A bunion, or hallux valgus, is a foot deformity that affects about 60 million Americans and results in approximately 400,000 surgeries in the U.S. annually, according to the company.

“This study demonstrated positive bone healing rates over progressive timepoints when utilizing biplanar plating without a cross-joint compression screw in procedures used to treat bunions or arthritis of the big toe joint,” said lead author Dr. Paul Dayton of the Midwest Bunion Center (Des Moines, Iowa), in a prepared statement. “The bone healing rates were quite encouraging, given this unique fixation approach allowed patients to undergo an accelerated recovery protocol and to initiate weightbearing in a post-operative boot within their first week of surgery.

“Overall, I’m very pleased with these results as they reinforce that I can offer this fixation option to my patients with a high level of confidence that they will experience reliable bone healing under an accelerated weight-bearing protocol.”

“The outcomes of this new study are noteworthy in that they closely mirror those reported in our 13-month multicenter dataset presented at the 2018 American Orthopaedic Foot & Ankle Society’s (AOFAS) annual meeting in Boston,” added Dr. Robert Santrock of West Virginia University and co-author on this new publication. “In the AOFAS dataset, the 61 feet treated with Lapiplasty 3D Bunion Correction showed low 1.6% symptomatic non-union rate and 3% radiographic recurrence rate. Patients in the AOFAS study initiated weightbearing in a post-operative boot at an average of 10.5 days, which is consistent with this new study.”

“The rapid time to weightbearing, high rate of bone healing, and low implant removal rate reported in this study further highlight the patient benefits of biplanar plating — the fixation method used in the Lapiplasty procedure,” said Treace Medical CEO John  Treace. “The study represents the 9th peer review publication supporting the Lapiplasty procedure, another important milestone for our company.”

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Medtronic seeks another bite at the apple in $24m patent loss to spine doc inventor

Medtronic logo updated

Medtronic (NYSE:MDT) asked a federal appeals court for a full-bench review of its nearly $24 million loss in a patent infringement lawsuit brought by a physician inventor.

In February 2014, Dr. Mark Berry alleged that Fridley, Minn.-based Medtronic infringed on three patents covering a “system and method for aligning vertebrae in the amelioration of aberrant spinal column deviation conditions.”

In November 2016, a jury in the U.S. District Court for Eastern Texas sided with Barry, awarding $15.1 million for infringement of one patent, more than $2.6 million for infringement on the second and $2.6 million for overseas infringement. In January 2017 a judge reduced the $20.3 million verdict by $2.6 million, ruling that Barry did not present sufficient evidence on the overseas violation but upholding the U.S. infringement claims. Later that year, the court awarded total damages of nearly $24 million.

In January the U.S. Court of Appeals for the Federal Circuit issued a split 2-1 opinion affirming the lower court’s decision. In a March 27 filing, Medtronic asked the appeals court to seat its full complement of judges for a review of the case, arguing that the dissenting judge’s argument on one of the patents should carry the day.

“In Dr. Barry’s case, all of the foregoing considerations – the lack of records indicating experimentation, the normal fee charged, the control exercised, and the failure to inform customers of experimental purpose – would look the same if the surgeries were for commercial purposes. The only thing that affirmatively suggests these surgeries were experimental is that Dr. Barry said they were – after the fact, during litigation. As a matter of law, that is insufficient to show experimental purpose,” Judge Sharon Prost wrote in the dissent. “The record in this case shows that Dr. Barry waited too long to file for the ‘358 patent and that the on-sale bar applies.”

“Rehearing is warranted to reaffirm that such post hoc testimony, unsupported by contemporaneous objective evidence, cannotsave otherwise-invalid patent claims from operation of the statutory on-sale and public use bars,” Medtronic wrote in its rehearing petition.

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Sterilization plant closures: Here’s why you need to care

(Image by Jose Fontano on Unsplash)

The recent shutdown of a Sterigenics medical device sterilization plant in Willowbrook, Ill. has affected medtech giants such as Becton Dickinson (NYSE:BDX), Boston Scientific (NYSE:BSX), Medtronic (NYSE:MDT), Smith & Nephew (NYSE:SNN) and Stryker (NYSE:SYK), according to an FDA list of devices processed at the sterilization plant.

Medium-sized and smaller firms, including Teleflex Medical (NYSE:TFX), Arthrex and ArthroCare also had devices processed there. The Willowbrook plant sterilized 594 types of devices, including sutures, clamps, knives, stents and needles. With a Viant sterilization plant in Grand Rapids, Mich. slated to close later this year, the FDA is warning of spot shortages, and smaller medtech companies may be the hardest hit.

Get the full story on our sister site, Medical Design & Outsourcing.

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FDA clears first molybdenum rhenium pedicle screw

Mirus

The FDA today cleared Mirus‘s Europea pedicle screw system, which is composed of its MoRe proprietary molybdenum rhenium superalloy, making it the first such device approved with the new class of implant material.

The Atlanta-based medical device company said that the MoRe proprietary alloy is intended to provide improved strength, ductility, durability and biological safety.

“Spine deformity surgery in adults remains plagued by the poor performance of current implants with rod failure occurring in 18%-20% of patients. The MoRe alloy shows great promise in improving the durability of adult spine deformity constructs. This advance will help prevent early revision surgery and improve outcomes in adult deformity surgery in particular,” Dr. Munish Gupta of Washington University said in a press release.

“This new material with its greater strength, fatigue resistance and superior biological properties will allow us to make lower profile foot and ankle implants leading to smaller surgical exposures and reduced revision rates,” Dr. James Nunley of Duke University said in a prepared statement.

Mirus added that it believes the MoRe alloy will allow for a new generation of smaller, stronger, more durable and bio-friendly implants which it hopes will result in less tissue disruption, faster recovery and improved patient outcomes.

“FDA approval of the Europa Pedicle Screw System with our patented MoRe superalloy is the culmination of over ten years of research and development.  Our scientists and engineers working with world class metallurgists have created the greatest advance in medical implant material technology in at least four decades. The MoRe superalloy will revolutionize many aspects of the medical device industry as the first alloy approved by the FDA for use in an implant which is not based on titanium, cobalt or iron with their inherent limitations. The FDA requires a rigorous level of scientific investigation to establish the safety and effectiveness of a spine implant that utilizes a new medical alloy. In response to FDA guidance, our scientific team led by Jordan Bauman, VP of Regulatory, developed a comprehensive body of evidence which served as the basis for approval of this major advance in patient care. We are fortunate to be collaborating with an outstanding worldwide group of orthopaedic and neurosurgeons in developing transformative spine solutions. Additionally, MiRus is rapidly expanding into other orthopaedic applications such as foot and ankle and has made significant progress in cardiovascular applications of the MoRe® superalloy,” founder & CEO Dr. Jay Yadav said in prepared remarks.

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J&J’s DePuy Synthes goes after Orthofix, ex-reps in poaching lawsuit

DePuy Synthes, OrthofixJohnson & Johnson (NYSE:JNJ) unit DePuy Synthes last week sued Orthofix (NSDQ:OFIX) and a pair of former DePuy sales reps, alleging that its rival lured the reps and two other colleagues away so it could poach DePuy clients in Alabama and Texas.

According to the suit, filed in the U.S. District Court for Eastern Texas, DePuy hired Thomas Wells and Michael Sewell in 2012 as sales consultants for DePuy Synthes for the territory around Dothan, Ala. After the duo quit in March 2017 within hours of each other, the suit alleged, routine inventory checks at one of their clients revealed Orthofix devices and instruments that were sterilized and ready for surgery at on of their DePuy clients, Southeast Alabama Medical Center.

“In other words, Orthofix equipment had been brought in and was ready to be used in surgery,” according to the suit. And although DePuy products were slated to be used in multiple procedures that week, all but one of those cases were canceled.

“Despite its best efforts, DePuy Synthes has not done any further business at SEAMC,” according to the March 22 lawsuit. “Orthofix was able to convert an account worth millions of dollars practically overnight by using the investments DePuy Synthes made its customers relationships, goodwill, specialized training, and confidential information through Messrs. Wells and Sewell, inducing them to leverage these investments to Orthofix’s benefit.”

The lawsuit does not name Wells and Sewell as defendants, but two other sales consultants in its Longview, Texas, sales region were named in the suit. DePuy accused Orthofix of targeting Scott Mackey and Miranda Middleton in late 2017, alleging that they accompanied “key DePuy Synthes’ surgeon customers to visit Orthofix’s headquarters in Lewisville, Texas,” a month before their “abrupt and simultaneous resignations.”

“Mackey and Middleton encouraged and aided each other in deciding to leave DePuy Synthes and join Orthofix and assisted each other in executing a simultaneous resignation from DePuy Synthes,” the suit alleged. “DePuy Synthes learned shortly after their resignations, but while they were still employed with DePuy Synthes, that Mackey and Middleton started to make arrangements to have Orthofix equipment available at their accounts while they were still employed with DePuy Synthes.”

The lawsuit seeks actual and compensatory damages, disgorgement of all profits generated by Wells Sewell, Mackey and Middleton, legal costs and interest.

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Appeals court declines full review of $254m Zimmer loss to Stryker

Stryker, Zimmer BiometA federal appeals court declined a full review of its earlier decision to affirm a $248 million win for Stryker (NYSE:SYK) in its surgical tool patent case against Zimmer Biomet (NYSE:ZBH).

The U.S. Court of Appeals for the Federal Circuit last December upheld treble damages in the case, based on a U.S. Supreme Court decision in Halo Electronics v. Pulse Electronics that relaxed the standard for enhanced damage awards in patent infringement cases. Zimmer Biomet appealed that per curiam decision, asking for both a three-judge panel and the full Federal Circuit bench to re-evaluate the case. The court denied both petitions March 19, setting March 26 as the date for issuing the mandate of the court.

The case dates back to December 2010, when Stryker sued Zimmer the U.S. District Court for Western Michigan, alleging infringement of three patents covering wound debridement technology by Zimmer’s Pulsavac Plus device. In February 2013 a jury awarded $70 million to Stryker; Judge Robert Jonker trebled the damages in August of that year.

The Federal Circuit in 2014 rolled back that $228 million ruling, finding that Stryker failed to prove willful infringement. Stryker appealed to the Supreme Court, which vacated the appeals court’s ruling and ordered it to reconsider the case. The Supremes found that the Federal Circuit’s test was too rigid and allowed egregious infringers to evade liability.

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Ex-NuVasive CEO Lucier to head new M&A firm

Ex-NuVasive CEO Gregory Lucier will lead new M&A-focused company Corza Health.

Recently departed NuVasive (NSDQ:NUVA) CEO Gregory Lucier will lead a new company formed to acquire medtech and life sciences firms and assets.

Lucier, 54, is partnering with Chicago-based private equity firm GTCR to form the new company, Corza Health, in San Diego. GTCR holds stakes in Regatta Medical, which owns laser micro manufacturer Resonetics and Sotera Health along with life sciences, technology, and financial and business services companies.

Get the full story on our sister site, Medical Design & Outsourcing.

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