Medtronic launches Grafton DBM in Japan

Medtronic logo updated

Medtronic (NYSE:MDT) said today that it launched its Grafton demineralized bone matrix bone grafting product in Japan.

The Fridley, Minn.-based company touted the Grafton DBM as the first and only demineralized bone matrix product available in Japan, having won clearance from the country’s PMDA last August.

The newly launched Grafton DBM is a bone graft extender, bone graft substitute and bone void filler intended for use in bony voids or gaps in the skeletal system. The company added that the Grafton DBM has consistently high osteoconductivity scores and that it is the “most utilized and scientifically-studied DBM on the market.”

“Our unmatched combination of biologic therapies, services and expertise help surgeons meet the needs of each unique patient. Grafton is an important option within our comprehensive, market-leading biologics portfolio, and we’re excited that surgeons in Japan now have access to this clinically-proven osteoinductive bone graft product,” spine division prez Jacob Paul said in a prepared statement.

Medtronic said that the Grafton DBM is comprised of multiple forms, and that it is launching the Grafton Putty, Grafton Matrix and Grafton Strip in Japan.

Yesterday, Medtronic said that it won 510(k) clearance from the FDA for its Accurian radiofrequency nerve ablation device for treating chronic pain.

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Innovasive rebrands as Amplify Surgical

Amplify Surgical

Spinal device manufacturer Innovasive said yesterday that it is rebranding under the moniker Amplify Surgical.

The Mission Viejo, Calif.-based company began the name change in January and said that it expects the rebranding process to continue through the end of the first quarter.

“The Amplify Surgical name better emphasizes our commitment to delivering new, cutting-edge, surgical solutions that reestablish the standard of care for our surgeon customers and their patients. In addition, the new name and brand better represents the Company’s inventive culture and product pipeline,” CEO Andy Choi said in a press release.

Amplify Surgical’s first product is the DualX dual expanding interbody fusion system, which won FDA clearance last October.

The system is comprised of titanium expandable interbody devices intended for use in transforaminal lumbar interbody fusion, posterior lumbar interbody fusion and lateral lumbar interbody fusion procedures, the company said.

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Orthofix wins FDA PMA nod for M6-C artificial cervical disc


Orthofix (NSDQ:OFIX) said yesterday that it won FDA approval for its M6-C artificial cervical disc, intended for treating patients suffering from cervical disc degeneration.

The Lewisville, Texas-based company said that the M6-C artificial cervical disc was developed by Spinal Kinetics, which it acquired last April.

The newly cleared M6-C is a next-gen artificial disc intended to replace an intervertebral disc damaged by cervical disc degeneration. The system is designed to restore physiological motion to the spine and is indicated as an alternative to cervical fusion, Orthofix said.

Pre-market approval of the device came based on results from an FDA investigational device exemption study of the system which evaluated the safety and effectiveness of the M6-C as compared to anterior cervical discectomy and fusion for treating symptomatic cervical radiculopathy with or without cord compression, the company said.

Two-year results from the trial indicated that 90.5% of patients who received the disc showed a meaningful clinical improvement on the Neck Disability Index versus only 79.9% in the ACDF cohort, as well as improvements in arm pain in 91.2% of M6-C patients, higher than the 77.9% reported in ACDF patients.

Data from the trial indicated that patients who received the M6-C disc showed a preserved range of motion in flexion-extension and lateral bending.

A total 80.6% of M6-C disc patients and 85.7% of ACDF patients reported taking pain medications for their cervical spine condition, Orthofix said. At 24 months, 14% of M6-C patients reported still taking pain medications, compared to 38.2% of the ACDF cohort.

Additional surgeries at the treated level was required in only 1.9% of M6-C patients, lower than the 4.8% rate for ACDF patients, the company said.

“Cervical disc degeneration is a common condition that can cause pain in the neck, shoulders, arms and hands and lead to numbness and weakness in the arm or hands. Often this condition is the result of a vertebral disc that has deteriorated or been damaged due to the natural aging process or an injury. For many of these patients, the M6-C artificial cervical disc will give us the ability to replace the patient’s damaged disc with one that closely mimics their natural disc, enabling them to regain motion and return to their normal activities,” M6-C artificial cervical disc IDE study investigator Dr. Rick Sasso of Indianapolis’ Indiana University School of Medicine said in a prepared statement.

Orthofix said it plans to launch the M6-C artificial cervical disc this year through a controlled, limited market launch in the U.S. with an extensive training and education program. The device already has CE Mark approval in the European Union.

“With the approval of the M6-C artificial cervical disc, Orthofix now has the industry’s most comprehensive portfolio of cervical spine products to best serve our surgeon customers and patients. In addition to a full line of anterior, posterior and interbody fusion cervical implants, we offer the CervicalStim device, the only FDA-approved cervical bone growth stimulation therapy, and the Trinity Elite allograft, a market-leading allograft developed in partnership with MTF Biologics. The launch of the M6-C artificial cervical disc in the U.S. will complement this existing spine portfolio and represents a significant milestone in the execution of our strategy to accelerate topline growth,” Orthofix prez & CEO Brad Mason said in a press release.

Earlier this week, Orthofix said that it acquired Florida-based medical device distributor Options Medical for an undisclosed amount.

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Relievant back-pain device study stopped for positive results

Relievant Medsystems said it has halted enrollment in a clinical trial of its Intracept lower-back pain device due to the device’s superiority over non-surgical management.

The Level I Intracept study found a “highly significant reduction” in the Oswestry Disability Index (ODI) score in patients treated with the Intracept procedure over patients in the non-surgical management arm. The trial’s independent data management committee recommended that investigators stop enrollment and offer Intracept treatment to control-arm patients, according to the Minneapolis, Minn.-based company.

The interim analysis of the primary endpoint 104-participant trial demonstrated a 20.9 point difference in mean ODI reduction at three months between the Intracept arm and the non-surgical management arm. The Intracept-treated patients reported a 25.3 point reduction in ODI from baseline at three months. One-year results from a prior study released in February 2018 showed a statistically significant difference between patients treated with Intracept and a sham treatment cohort.

“This is the second Level I study that has demonstrated clinically significant improvement in pain and function for patients with modic changes on MRI and solidifies the Intracept procedure as a compelling early treatment option for patients with (chronic lower back pain),” said principal investigator Steven Garfin, M.D., interim dean, University of California San Diego School of Medicine, in a prepared statement.

“Stopping a Level I trial early for superiority is an extremely rare event and we are thrilled with this result,” said Relievant Medsystems CEO Kevin Hykes. “The Intracept procedure has demonstrated compelling and consistent clinical results in both sham-controlled and real-world Level I studies. The combined strength of these studies provides convincing evidence of the outcomes that patients and physicians can expect from the Intracept procedure.”

The full results of the Intraceptstudy are expected to be presented and published later in 2019.

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Globus Medical lands Anthem coverage win for Secure-C spinal implant

Globus MedicalGlobus Medical (NYSE:GMED) last week said it won a coverage decision for its Secure-C cervical spine implant from health insurance giant Anthem (NYSE:ANTM).

Audubon, Pa.-based Globus said the decision means the device is covered by the major third-party payers in all 50 states. Anthem has more than 73 million lives under its coverage umbrella, according to Globus. The Secure-C device won pre-market approval from the FDA in 2012 and is is designed to restore normal movement to the neck in patients with disc problems that produce neck and arm pain. It consists of 2 cobalt-chrome endplates and a central polyethylene core that mimics the function of a healthy spinal disc.

Globus said that its seven-year follow-up data show that patients implanted with the device showed statistically superior overall success results (86.3% vs. 70.0% of patients treated via anterior cervical discectomy & fusion); statistically superior composite FDA-defined overall success (79.2% vs. 63.6% for the ACDF comparator); a higher rate of patients showing at least 25% improvement in Neck Disability Index, a measure of pain and function (90.4% vs. 86.0%); a lower rate of subsequent surgery at the original treatment site (4.2% vs. 15.3%); and a lower rate of adjacent-level surgery (4.2% vs. 16.0%).

“The long-term clinical results validate that Secure-C creates a significant improvement in patients’ lives over the long term, an important factor in expanding payer coverage,” president Anthony Williams said in prepared remarks. “With the addition of Anthem, Secure-C is now covered by all major third-party payers in every state and strengthens our position for growth in the cervical artificial disc market.”

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Medtronic touts U.S. launch of Mazor X Stealth spinal robot-assisted surgery device

Medtronic logo updated

Medtronic (NYSE:MDT) said today that it launched its Mazor X Stealth robotic-assisted spinal surgical platform in the U.S., touting its recent use in its first commercial procedures.

The first uses of the system took place at Louisville, Ky.’s Norton Healthcare and Reston, Va.’s Reston Hospital Center, the Fridley, Minn.-based medtech giant said.

“The marriage of robotics and navigation represents the future of computerized planning and execution in spine surgery. Robotics and navigation have both been shown to improve accuracy and precision in spine surgery. The Mazor X Stealth edition is a revolutionary new technology that uses cutting-edge software to plan the surgical procedure, then uses a robotic arm to guide implants and instruments through the steps of the surgical procedure with precision, while simultaneously using real-time imaging feedback to ensure the plan is being carried out as desired,” Dr. Christopher Good of Reston Hospital Center and The Virginia Spine Institute said in prepared remarks.

The newly launched spinal robotic platform incorporates Medtronic’s Stealth software technology into their recently acquired Mazor Robotic’s Mazor X robotic-assisted surgical platform, the company said.

The addition of Stealth technology is intended to improve workflow predictability through the use of real-time image guidance, visualization and navigation using 3D planning and information systems, the company added.

“It is rare that huge sectors of technology such as robotics and navigation merge into a sole platform as found in the Mazor X Stealth edition. Combined, these may provide more predictable and reliable execution of our procedure workflows. Computerized surgical planning, 3-D assessment of spine anatomy, robotic guidance and live navigation feedback are designed to provide a higher degree of accuracy throughout the surgical procedure,” Dr. Jeffrey Gum of Norton Leatherman Spine said in a prepared statement.

The system won FDA clearance in November and is now available in the U.S. Medtronic said it plans to launch the system in key regions throughout 2019.

“As part of our Surgical Synergy strategy, we believe Mazor X Stealth edition will accelerate the advancement and adoption of robotic-assisted and navigated surgical technologies in spine. Medtronic is committed to transforming the future of spine care by offering procedural solutions that integrate implants, biologics and enabling technologies like navigation, 3-D imaging, robotics and powered surgical tools,” Medtronic restorative therapies group prez Geoff Martha said in a press release.

The product is the first to come out of Medtronic’s acquisition of Mazor, originally announced in September and closed late last month.

The world’s largest medical device maker has held a position in Mazor, which makes the Mazor X guidance system and the Renaissance robot-assisted spine surgery platform, since May 2016. Last September they closed the third, $40 million tranche of the investment, giving Medtronic a 10.6% stake it paid $72 million for.

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Appeals court backs spine doc inventor in $24m patent infringement spat with Medtronic

Medtronic logo updated

The U.S. Federal Circuit Court of Appeals this week affirmed a nearly $24 million verdict in favor of a physician inventor in a patent spat with medtech giant Medtronic (NYSE:MDT), according to recently released court documents.

In February 2014, Dr. Mark Berry filed a suit against Medtronic alleging 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 Dr. Barry and awarded him $15.1 million for the infringement of one of the patents in the U.S., more than $2.6 million for infringement on the second patent in the U.S. and $2.6 million for the infringement of the patent overseas.

In January 2017 a judge reduced the $20.3 million verdict by $2.6 million, ruling that Barry did not present sufficient evidence that the company infringed one of its patents overseas but upholding the U.S. infringement claims.

In May of the same year, Judge Ron Clark awarded $15.1 million for infringement of 1 patent, 20% enhanced damages of $3.0 million, $2.6 million for infringing the 2nd patent, plus 20% enhanced damages of $525,000, pre-judgment interest of $2.4 million, post-judgment interest at a 1.07% rate and court costs.

The Appeals Court yesterday issued a split 2-1 opinion affirming the decision of the jury, leaving Medtronic on the hook for approximately $23.5 million, according to the court documents.

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Abbott touts effective pain management, lower energy use in BurstDR SCS study results

Abbott (NYSE:ABT) late last week released results from a study of its BurstDR spinal cord stimulation technology, touting that it provided as effective pain relief as standard SCS despite providing lower-energy, intermittent stimulation known as “microdosing,” for patients with chronic intractable pain.

Results from the BOLD study were presented at the 22nd Annual North American Neuromodulation Society Meeting in Las Vegas, the Chicago-area medtech company said.

All patients in the BOLD trial reported experiencing pain relief with less than six hours of battery use per day while being treated with BurstDR, with 43% of patients reporting pain relief with less than two hours of battery use.

Abbott said that data from the trial may indicate a potential strategy for prolonging SCS battery life while still maintaining optimal pain relief, and could improve the viability of recharge-free SCS devices.

“While stimulation with BurstDR has been shown to provide superior efficacy compared to traditional stimulation in previous studies, battery consumption is an important consideration for physicians as we look to maximize the life of the devices for our patients and control their pain. This new data reinforces the benefits of BurstDR stimulation but also shows that microdosing BurstDR stimulation may help us extend device battery life for patients, which may help improve patient satisfaction with their SCS therapy,” primary investigator Dr. Timothy Deer of Charleston W.V.’s The Spine and Nerve Center of the Virginias said in a press release.

In a separate study, dubbed BURST(able), data indicated that patients who did not receive effective pain relief from their previous SCS therapy found restored pain control and reduced opioid dependency after switching to one of Abbott’s BurstDR waveform devices, the company said.

The BURST(able) trial was non-industry sponsored, and evaluated patients experiencing loss of pain relief from their non-Abbott SCS systems who switched to a BurstDR waveform device. Of the patients in the trial who were surgically implanted with the new device, 60% to 72% reported a reduction in pain and 41% to 52% a reduction in opiate consumption, the company said.

“As a pain specialist, one of the most difficult things to combat is patients developing a tolerance to their therapy and seeing SCS therapy lose efficacy over time. Loss of efficacy often leads to patients reverting back to chronic opioid therapy or left with no good alternative therapy options. I’m encouraged to see that, by switching to Abbott’s BurstDR stimulation, we can offer patients a neuromodulation treatment that is safe and effective while reducing reliance on opioid medication, regardless of their prior treatment,” primary investigator Dr. Corey Hunter of the Ainsworth Institute of Pain Management said in a prepared release.

“BurstDR stimulation has been used clinically now for many years and these latest data indicate that we’ve just scratched the surface of what’s possible. Our goal is to continue studying BurstDR stimulation to maximize its potential, even at extremely low doses, and allow people with chronic pain to live their best lives without the burden of recharging their devices and the fear of losing efficacy over time,” Abbott chronic pain therapies medical director Dr. Allen Burton said in a prepared statement.

Today, Abbott said that it won FDA approval for its TactiCath Sensor Enabled contact force ablation catheter intended for use in treating atrial fibrillation.

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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 (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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