Conformis: Yale study shows customized knee implants save money

ConformisConformis (NSDQ:CFMS) is touting results of a study that found that the average overall cost of care was nearly $1,700 less among Medicare patients treated with the company’s customized individually made knee implants.

Researchers at the Yale School of Medicine and Baker Tilly Virchow Krause conducted the study, which reviewed episode expenditures for all of 2015 among 4,434 Medicare beneficiaries, 739 receiving Conformis customized implants and 3,695 receiving standard off-the-shelf implants.

Results, presented at a recent Knee Society Meeting, found the average overall episode of care was $18,585 for patients with Conformis implants, versus $20,280 for patients with off-the-shelf implants.

Dr. Mary O’Connor, director of the Center for Musculoskeletal Care at Yale School of Medicine and the study’s lead researcher, described the study as the first long-term analysis of the economic impact of Conformis implants among Medicare-funded patients.

“The largest reductions in episode spending were associated with Conformis CIM patients who had overall fewer costs associated with the procedure and hospital stay as well as their post-acute care needs,” O’Connor said in a news release. (Note: O’Connor’s research institute receives support from Conformis, but O’Connor receives no personal compensation from the company.)


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NuVasive wins FDA, CE Mark for Precice internal bone transport system


NuVasive Inc. (NSDQ:NUVA) said today that it won FDA 510(k) clearance and CE Mark clearance in the European Union for its Precice bone transport system.

The San Diego, Calif.-based company touted the system as the only all-internal system indicated for use in segmental bone loss treatment in the tibia and femur resulting from trauma or infection.

The Precice bone transport system includes an implantable magnetic intramedullary nail with a dual slot intended to support the transport of an intercalary bone segment to allow for health regeneration, NuVasive said. Following implantation, an external remote control is used to move the bone segment up to 10 centimeters based on patient needs, the company added.

The newly cleared all-internal system does not require patients to wear an external device for an extended period of time, reducing the potential for increased pain and risk of infection, NuVasive said.

“The Precice Bone Transport System enables the treatment of complex segmental defects using the proven, less invasive, Precice magnetic technology which is a game-changer for my practice and patients. Patients who undergo a bone transport procedure due to trauma, tumors or infection are already dealing with significant issues regarding their condition, and the extreme time commitment it takes to reconstruct these significant bone defects. To be able to offer a treatment option that allows them to avoid many of the traditional complications and physical challenges of dealing with an external fixation system that is on their limb for an extended period of time is a significant development,” Dr. J. Watson of the University of Arizona College of Medicine said in a press release.

NuVasive said that it plans to launch the system commercially in the U.S. and Europe in the third quarter of this year.

“The FDA clearance and CE mark approval for use of the Precice Bone Transport System are an exciting step forward for NSO as we continue to demonstrate how our innovative technologies can transform the orthopedic trauma space. With this clearance, we are now able to offer surgeons an all-internal, reliable treatment option that provides a simple approach to salvage both limbs and joints for complex limb reconstructions, such as patients with invasive tumors or large segmental defects. We remain committed to the ongoing development of innovative orthopedic solutions that equip surgeons to fulfill unmet clinical needs and, ultimately, improve the lives of patients,” NuVasive Specialized Orthopedics president Massimo Calafiore said in a prepared statement.

Earlier this month, a report emerged suggesting that Smith & Nephew (NYSE:SNN) is in discussions to pick NuVasive in a deal that could be worth more than $3 billion.

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Trice Medical to acquire SegWay Ortho

Trice Medical

Trice Medical said today that it inked a deal to acquire SegWay Orthopaedics for an undisclosed amount.

SegWay Ortho produces solutions for minimally invasive orthopedic procedures, including its flagship Endoscopic Carpal Tunnel Release system, a device intended to support minimally invasive carpal tunnel surgeries, Malvern, Penn.-based Trice Medical said.

The company’s SegWay platform is also used in minimally invasive surgery for cubital tunnel syndrome, gastrocnemius equinus contracture and planar fasciitis, Trice Medical added.

“We’re excited for SegWay to join forces with Trice. In just over five years, growing at 30 to 40 percent year-on-year, we’ve created tremendous traction among orthopedic surgeons. Teaming with Trice Medical, which is advancing technologies that involve cameras and ultrasound, rounds out our offering for those doctors,” SegWay founer & CEO Stuart Seymour said in prepared remarks.

“The SegWay acquisition transforms Trice Medical into the first company that offers both minimally invasive orthopedic diagnostic and surgical solutions. We’re looking forward to integrating the SegWay offerings and building on our combined strengths. One of the areas we’re looking at is using our minimally invasive camera technology in the operating room as well,” Trice Medical CEO Jeffrey O’Donnell Sr. said in a press release.

Last month, Trice Medical said that it added more than $18 million to the $19 million Series C round it closed back in 2017.

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Report: J&J, plaintiffs close to settling majority of Pinnacle suits

Johnson & Johnson

Johnson & Johnson (NYSE:JNJ) subsidiary DePuy is close to settling the majority of consumers lawsuits against it related to the alleged defectiveness of its Pinnacle metal-on-metal hips, according to a Bloomberg report.

A federal jury in Dallas that was hearing testimony in damage claims brought by Pinnacle recipients was dismissed upon news of the settlement deal, according to the report.

“The parties have reached an agreement that hopefully will resolve most, if not all, of the litigation,” attorney Mark Lanier, who leads one of the consolidated 10,000-suit litigations against J&J, said, according to Blloomberg.

The company has not yet officially commented on the case, and may not speak on the matter in the future, DePuy spokesperson Mindy Tinsely said, according to the report.

The settlement comes only weeks after J&J’s DePuy reached a $120 million settlement deal with 46 U.S. Attorneys General in a case alleging that the company illegally promoted its Pinnacle Ultamet and ASR XL metal-on-metal hip implants.

Last December, another Bloomberg report suggested that J&J was willing to put more than $400 million on the table to settle consumer allegations that its Pinnacle line of metal-on-metal hips were defective and caused problems including metal poisoning.

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Ortho RTi touts rotator cuff study results at conference

Startup Ortho Regenerative Technologies (CNSX:ORTH) said two new studies have validated its product’s ability to improve the repair of two distinct joint tissues – the rotator cuff tendon and articular cartilage.

The rotator cuff study results were presented yesterday at the Annual Orthopaedic Research Society meeting in Austin, Texas.

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

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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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Sirakoss wins CE Mark for Osteo3 bone graft substitute


Sirakoss said yesterday that it won CE Mark clearance in the European Union for its Osteo3 novel nanosynthetic bone graft substitute.

The Aberdeen, Scotland-based company said that its Osteo3 consists of an inorganic matrix intended to be completely reabsorbed into the bone.

Sirakoss added that the newly cleared bone graft substitute features a unique surface chemistry designed to catalyze rapid and complete bone regeneration following a fracture or for support after corrective surgeries.

“Osteo3 is the first of our new generation of bone substitute products to receive CE Mark, a major milestone for Sirakoss. We believe our approach could provide the definitive synthetic bone graft product and feedback from surgeons on performance has been very encouraging. The positive results in studies achieved to date suggests that Osteo3 is a potential game-changer in the synthetic bone graft substitute market, providing significant advantages to patients and surgeons, including in the most challenging bone fracture indications. Sirakoss’ priority is executing on its commitment to delivering robust clinical data demonstrating safety and effectiveness of this exciting new product,” director Tom Buckland said in a prepared statement.

“We designed Osteo3 to address an increasing demand for a bone graft substitute that has the efficacy of autograft but overcomes the well reported problems of donor site pain for a significant number of patients. Our initial studies have confirmed both of these important aspects with our novel, fully nanosynthetic material. We are also working on the next generation of Osteo3, which will provide additional benefits to surgeons, in particular little or no prep in the surgical suite,” ,” co-founder & RAD director Iain Gibson said in a press release.

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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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Zimmer Biomet wins FDA nod for Rosa Knee robotic surgical system

Zimmer Biomet logo

Zimmer Biomet (NYSE:ZBH) said today that it won FDA 510(k) clearance for its Rosa Knee robotically-assisted total knee replacement surgery platform.

The newly cleared Rosa Knee system includes 3D pre-operative planning tools and real-time intraoperative data on soft tissue and bone anatomy to improve bone cut accuracy and range of motion gap analysis, the Warsaw, Ind.-based company said.

“Complementing the skill and expertise of the surgeon with Rosa Knee’s robotically-assisted technologies can improve accuracy, precision and consistency, which can improve patient satisfaction, clinical outcomes and efficiency. Rosa Knee functions as a surgical assistant that gives me the tools and real-time data to perform bone cuts with greater precision and improve patient-specific soft-tissue balancing and implant alignment, without losing my feel for a natural fit and flexion,” Dr. Christopher Cannova of the Washington Joint Institute at OrthoBethesda said in a prepared statement.

Zimmer Biomet said that the Rosa Knee also features its proprietary X-Atlas imaging protocol, which provides X-ray based preoperative imaging to create a 3D model and plan of the patient’s bone anatomy.

“We are excited for the launch of Rosa Knee, which brings together Zimmer Biomet’s robotics technology with our industry-leading Knee implants to help surgeons personalize surgical procedures for their patients. Zimmer Biomet is committed to leading the industry in bringing differentiated and holistic solutions to market that address the needs of our customers and improve patient outcomes,” orthopedics group prez Ivan Tornos said in a press release.

In November, Zimmer Biomet said that it won FDA 510(k) clearance for its Persona revision knee implant.

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Orchid Orthopedic Solutions acquired by European private equity outfit

Orchid Orthopedic SolutionsNordic Capital has acquired a majority stake in Orchid Orthopedic Solutions (Holt, Mich.), a major design and manufacturing outsourcer in the orthopedic medical device space.

Financial terms of the deal – announced Jan. 21 – were not disclosed.

While the Nordic Capital Fund IX is buying a majority stake in Orchid, previous owner Altor Fund III will keep a significant minority holding.

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

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