Ulrich Medical launches next-gen Solidity vertebral body replacement

Ulrich Medical

Musculoskeletal implant tech dev Ulrich Medical USA said today that it launched the next-gen Solidity vertebral body replacement device.

The St. Louis-based company said that it won FDA clearance for the device less than 60 days prior to the launch, and touted that the first commercial procedure with the device has already been performed in Palm Springs, Calif. late last month by Dr. Blake Berman of the Desert Regional Medical Center.

“I am excited to be working with the technological leader in expandable vertebral body replacement devices on the development of the new Solidity device. Solidity provides surgeons with an excellent number of options to accommodate all surgical approaches and vertebral body replacement indications including trauma, tumor, and deformity while addressing the subtleties of each patient’s unique anatomy. In addition, surgeon application of this device is simple and secure, and it allows for complete assembly and disassembly of the implant and end caps for easy reconfiguration during surgery,” Dr. Berman said in a press release.

The newly launched Solidity VBR implant consists of a main center piece with 625 unique end cap configurations, the company said. The system is designed so that end caps on it can be attached in a full 360° orientation with the Solidity center piece, which the company claims maximizes the range of device access for multiple surgical approaches.

“We are very pleased to release the Solidity VBR to the market in response to continued surgeon demand for additional corpectomy treatment options for their patients. The Solidity product incorporates more than forty years of our unparalleled experience in the research, development, manufacturing and commercialization of expandable spine implant technologies worldwide,” chief commercial officer Erika Laskey said in a press release.

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NuVasive wins expanded FDA nod for Monolith corpectomy system

NuVasive

NuVasive (NSDQ:NUVA) said yesterday that it won expanded FDA 510(k) clearance for its Monolith corpectomy system, now cleared for use in cervical corpectomy procedures.

The system is now cleared for procedures in the cervical spine, between the C3-C7 vertebral bodies, to treat diseased or damaged vertebral body caused by fractures, tumors, osteomyelitis or to support reconstruction following corpectomy for the decompression of the spinal cord and neural tissue in cervical degenerative disorders, the San Diego-based company said.

The device was initially cleared in 2015 for use in thoracolumbar corpectomy procedures, NuVasive said. The system features a monolithic cage made from PEEK and modular endcaps for anatomical personalization.

“Expanding the indicated use of our Monolith corpectomy system to include cervical corpectomy procedures demonstrates the company’s continued commitment to expanding our cervical spine interbody portfolio. We are pleased to provide surgeons with a PEEK cervical interbody solution to help round out our cervical portfolio as we continue to advance our mission to improve patient lives,” strategy, tech & corp dev prez Matt Link said in a press release.

Last month, NuVasive said that it won FDA 510(k) clearance for Cohere porous PEEK implants that are part of its Extreme Lateral Interbody Fusion surgical spinal procedures.

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Doc inventor wins $113m in royalties spat with Medtronic

Medtronic logo updatedA state court jury in Indiana last week reportedly awarded a $112 million decision to a local spine surgeon turned medical device inventor in his five-year royalties dispute with Medtronic (NYSE:MDT).

Dr. Rick Sasso sued Medtronic in 2013, alleging that the world’s largest medical device maker shorted him on their royalties deal for the Vertex cervical spine system he helped develop, according to the Indianapolis Business Journal.

Sasso licensed some of his early inventions to Sofamor Danek, about a year before its $3.3 billion merger with Fridley, Minn.-based Medtronic in January 1999, the newspaper reported. Further deals for spine stabilization devices followed, including some that eventually hit the market under the Vertex brand. The company agreed to pay him 2% of net sales for eight years or the life of the patent if it it is used in a device covered by a valid patent claim. Sasso argued that the Vertex system is covered by several valid patents and that Medtronic left out other products that used Vertex components, undercounting the sales calculation for his royalties.

The $112.5 million verdict lodged Nov. 28 culminated a five-year campaign that saw Sasso lose several battles. In 2015 an Indiana state court found that he never transferred his patent to his corporation, meaning it could not have licensed the technology to Sofamor Danek. Medtronic, having already paid Sasso some $23 million, didn’t owe him anything more, according to the ruling, which was later upheld by the Indiana state appeals court.

After amending his complaint three times, Sasso found favor with a six-person Marshall County Circuit Court jury last week, which deliberated for six hours after a trial that lasted nearly a month, according to the business journal.

In a quarterly regulatory filing, Medtronic said it has “strong arguments to appeal the verdict” and plans to file post-trial motions appeal if necessary.

“The company has not recognized an expense in connection with this matter because it does not currently believe a loss is probable under U.S. GAAP,” the company said in the filing.

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Report: Folded Ranier Tech’s spinal implants cleared in EU after tiny trial, found to dissolve in patients

Ranier TechPlastic spinal implants from now-defunct Ranier Technology are allegedly moving and dissolving in patients, calling into question the validity of the short, low-powered trial that won the device’s approval, according to a Guardian report.

The device in question, known as the Cadisc-L, won CE Mark approval in the European Union based on results from a six-month, 30-patient study, according to the report. The device underwent investigation by researchers from October 2009 until June 2010, winning approval in August.

Now, the devices are at the center of legal action from a number of patients who have undergone explant procedures to remove the disks, some of which have “completely disintegrated,” according to The Guardian.

Nearly 50% of patients implanted with the Cadisc-L have had to undergo follow-up surgeries, and scientific evidence seems to indicate that similar issues were noted during development, according to the report.

The discs were also implanted into nine baboons in an earlier animal trial, according to The Guardian. Data from a 2009 review of animals in the trial indicated that “overall six months is a relatively short time to follow and implant up,” and that there were “worrying changes between the implant and the bone in all but one subject.”

Details from the human trial were not published, according to the report.

Asked to respond to the accusations, former Ranier Tech CEO Dr. Geoffrey Andrews told The Guardian that the devices used in the baboons were custom-made and dissimilar to the devices that eventually made it to the market.

Andrews defended the devices, stating that “Ranier spent over eight years and more than £20 million in the design, development and testing of Cadisc-L,” according to the report.

He went on to state that the company’s decision to pull the devices from the market in March 2014 was based on the conditions of four patients who had to undergo follow-up surgeries related to the implants, according to The Guardian.

The paper’s data comes from the recently released ICIJ’s “Implant Files,” released earlier this week. The report raised a number of questions about the quality of the regulatory bodies that approve medical devices.

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Paradigm Spines wins Coflex coverage from AmeriHealth Caritas

Paradigm Spine

Paradigm Spine said today it won coverage for its Coflex interlaminar stabilization device intended to treat lumbar spinal stenosis from AmeriHealth Caritas.

The Coflex interlaminar stabilization system is the New York-based company’s flagship device, and is designed for posterior lumbar preservation in patients with moderate to severe spinal stenosis.

With the coverage, an additional 5.3 million individuals will be able to receive treatments with the Coflex device, the company said.

“With this continued payor coverage momentum, we look forward to further expanding access to our Coflex solution, which is backed by more than 90 peer-reviewed published articles, including landmark long-term follow-up clinical studies, and spine medical society guidelines,” chair & CEO Marc Viscogliosi said in a press release.

Earlier this month, RTI Surgical (NSDQ:RTIX) agreed to put $300 million on the table for Paradigm Spine and its Coflex lumbar stenosis device.

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Zimmer Biomet recalls bone stimulators on contamination risk

Zimmer Biomet logoZimmer Biomet (NYSE:ZBH) recalled nearly 1,400 bone stimulators on the risk that they could be contaminated with bacteria or chemicals, the FDA said yesterday.

The Class I recall, denoting the risk of serious injury or death, covers 1,360 implantable bone growth and spinal fusion stimulators made and distributed between February 2015 and March 2018, including Zimmer Biomet’s Osteogen, SpF Plus-Mini and SpF-XL stimulators, the federal safety watchdog said.

The devices are designed to stimulate healing after spinal fusion procedures or long-bone breaks. The voluntary recall was launched Feb. 19 “due to a lack of adequate validation and controls to ensure that final products were clean and free from bacteria and chemical residue,” the FDA said.

“The lack of adequate validation and controls may or may not cause serious side effects for the patient including infection, tissue death, additional surgery for wound treatment and/or device removal, impaired wound and bone healing, the need for long-term antibiotic therapy, the potential for secondary gastroenteritis, swelling and infection around the spinal cord (epidural abscess), paralysis, damage to other organs or death,” the agency warned.

It’s the latest regulatory stumble for Warsaw, Ind.-based Zimmer Biomet, which received a warning letter from the FDA last summer over quality violations found during 2016 and 2018 inspections there.

The FDA inspected the North Campus facility in Warsaw just before Thanksgiving 2016, documenting numerous violations in a Form 483 m notification. The company’s lengthy reply that December detailed its actions in remediating the problem, noting that company-wide audits put in place after the $14 billion merger of Zimmer and Biomet had already turned up problems at the site. Zimmer said it cleaned house after the inspection, replacing five operations and quality executives as it sought to bring the facility back into compliance.

But a re-inspection last April resulted in another Form 483 and then the warning letter flagging “continuing, significant violations of the quality system regulations” found during the April 2018 inspections, including failure to show that its process for corrective and preventive actions can ensure that the plant meets finished product specifications and the lack of adequate training procedures. The inspectors also found problems with the North Campus facility’s design validation processes, its handling of non-conformance reports and its CAPA implementation, according to the warning letter.

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Quadriplegic Mayo scientist helps advance spine injury tech

Mayo Clinic

A team of researchers at Minnesota’s Mayo clinic, led by an individual who was left with quadriplegia from a teenage injury, are pushing the boundaries of spinal regeneration, according to a new Star Tribune report.

The group, led by spinal cord injury researcher Peter Grahn, has published findings from a study that suggests that electrical stimulation, over time, can help restore movement to paralyzed limbs.

Results from the study was published in the journal Natural Medicine, according to the report.

The researchers initially set out to replicate a similar study that showed that electrical stimulation could help individuals move paralyzed limbs, according to the Star Tribune.

In the Mayo clinic trial, investigators implanted an individual who had been left with severe spinal cord injuries due to a snowmobile accident with a Medtronic (NYSE:MDT) stimulator intended to treat pain. The device was used to stimulate the individual’s spinal cord, and over time, helped him regain the ability to move his legs.

Over time, the patient in the trial was able to sit up, stand and eventually take multiple steps with the help of a walker during stimulation, according to the Star Tribune report.

The results are joined by similar outcomes from other studies that show that there may be treatments possible for individuals with spinal injuries previously believed to be non-treatable.

“Research is suggesting that, no matter how far out the injury was, it doesn’t seem to matter,” Grahn said, according to the report.

Grahn told the Star Tribune that he had been motivated to research why spinal cord injuries are deemed “complete,” or non-recoverable, after suffering through his own life-changing spinal injury at 18.

“I still recall, early on after my injury, asking some of the medical people helping me, ‘Why does the spinal cord not recover or heart itself like a normal injury to your skin or something?’ They gave me basic answers that I could understand, but they also said it’s not totally understood. That sparked my interest,” Grahn told the paper.

Grahn was left with quadriplegia after sustaining injuries from diving into a shallow lake in 2005, just before he was set to leave to college. As an athlete, Grahn expected he would recover much of his physical capabilities as he had before with other injuries, but became depressed as the permanency of the situation set in, according to the Star Tribune report.

Only a year after the accident, Grahn enrolled in Southwest Minnesota State University with an interest in rehabilitation medicine. Mayo physician and researcher Dr. Anthony Windebank encouraged him to pursue a research program at the world-famous clinical, and Grahn eventually earned a doctorate in neuroscience and joined the Clinic in 2016, according to the report.

Research from Switzerland, released around the same time as the study from the Mayo Clinic, showed a similar case using a Medtronic stimulator, according to the Star Tribune.

Researchers in that study were able to show similar results, with patients able to regain mobility, but took the results a step further, as patients were able to walk even after the implant was shut off, according to the report.

Despite the optimistic outlook from the studies, Grahn told the Star Tribune that he tempers such hopes with the reality of his own experience, suggesting that hopes shouldn’t get too far ahead of actual results.

“I’ve been through enough of these – when these news pieces come out [promising cures] and then five years later it’s just five years down the road. I’m sensitive to the issues of giving false hope to the spinal cord community, even though hope is necessary,” Grahn told the paper.

Grahn and the research team at the Mayo Clinic are seeking additional funding to expand their work. So far, the team has worked with two individuals, though results on the second have not yet been released.

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Vertiflex touts reduced opioid use in Superion lumbar spinal stenosis trial

Vertiflex

Vertiflex yesterday released results from a trial of its Superion indirect decompression system in patients with lumbar spinal stenosis, touting a significant reduction in the number of patients using opioids to manage pain at five years post-treatment.

Results from the trial were published in the Journal of Pain Research, the company said.

“These findings demonstrate that treatment with IPD, a minimally-invasive treatment option for LSS, can provide effective pain relief while markedly decreasing the need for prescription opioid medications,” lead author Dr. Pierce Nunley of the Spine Institute of Louisiana said in a prepared statement.

The Carlsbad, Calif.-based company said that the Superion indirect decompression system won FDA premarket approval for treating lumbar spinal stenosis.

“With growing concerns over prescription opioid overuse and misuse, which can lead to addiction, any effective strategies that can decrease or even eliminate the need for opioid therapy in patients with LSS are welcome,” study author Dr. Tim Deer of the Spine and Nerve Center of the Virginias said in a press release.

In the 190-patient trial, investigators analyzed the type, dosage and duration of opioid medications through five years of post-operative follow-ups after receiving an interspinous process decompression treatment with the Superion device.

Vertiflex said that initially, nearly 50% of patients were using opioid medications, and that after five years that number had decreased by 85%.

“We are pleased by these published results demonstrating that use of the Superion device provides effective relief from back and leg pain in patients with LSS without the need for continuing opioid therapy. These results extend previous research showing that Superion results in long-term sustained clinical improvement in patients with LSS. Finding non-opioid approaches to treating pain is critical, and we are pleased to share these published findings and discuss their implications with the clinical community,” prez & CEO Earl Fender said in a prepared release.

In March, Vertiflex said that it raised a total of $45.3 million in a round of equity financing.

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PE firm Altus Capital buys ChoiceSpine

Altus Capital Partners, ChoiceSpine

Investment firm Altus Capital Partners said today it acquired spinal implant maker ChoiceSpine for an undisclosed amount.

Knoxville, Tenn.-based ChoiceSpine develops spinal products including minimally invasive cervical, thoracolumbar, interbody lateral and biologics kits and implants, the groups said.

“We recognize the need in the medical technology space for proven spinal products that can enhance the quality of life for spinal patients. ChoiceSpine, a global medical device corporation specializing in innovative solutions for both spinal fusion hardware and biologics, demonstrates a track record of proven innovation, strong sales growth, increased distribution and the necessity of their products in the marketplace,” Altus co-founder & senior partner Gregory Greenberg said in prepared remarks.

“We look forward to working with Altus in further developing our offerings as well as expanding into new product verticals to continue to grow the company and provide patient solutions for the treatment of spinal disorders,” ChoiceSpine co-founder Marty Altshuler said in a press release.

Last November, Altus Capital Partners said it inked a deal to acquire MGC Diagnostics Corp in a $50.3 million deal.

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RTI Surgical wins coverage nod for Simmetry implant

RTI Surgical

RTI Surgical (NSDQ:RTIX) said today that non-profit healthcare organization HealthPartners issued a positive coverage decision covering the company’s minimally invasive sacroiliac joint fusion surgery using the Simmetry system, effective November 1.

The Simmetry system is a minimally invasive surgical solution using decotrication technology, bone graft and threaded fixation to facilitate bone fusion and provide long-term pain relief, Alachua, Fla.-based company said.

“As a surgeon in the HealthPartners network who has experience using the Simmetry System, this positive coverage decision is a win for patients suffering from SI joint dysfunction. The Simmetry System is a minimally invasive surgical solution that promotes SI joint fusion through decortication, with a growing body of clinical evidence showing improvements in pain, disability and opioid use for SI joint patients,” Dr. Edward Santos of Minneapolis’ Summit Orthopedics said in a prepared statement.

“RTI is encouraged by HealthPartners’ decision, which expands access to the Simmetry System for patients with SI joint pain or dysfunction. The Simmetry System is supported by a growing body of evidence suggesting long-term pain relief for these patients. We are committed to advancing clinical data for the Simmetry System to aid in further payor decisions,” prez & CEO Camille Farhat said in a press release.

Earlier this month, RTI Surgical said that it agreed to put $300 million on the table for Paradigm Spine and its Coflex lumbar stenosis device.

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