FDA votes to bring the first synthetic cartilage product to the US

FDA ORTHO PANEL TO VOTE ON CARTIVA SYNTHETIC CARTILAGE IMPLANT (Orthopedics This Week)
Cartiva website
The FDA’s Orthopaedic and Rehabilitation Devices Panel will meet on April 20, 2016 to discuss, make recommendations, and vote on the premarket approval application (PMA) for the Cartiva Synthetic Cartilage Implant (SCI), sponsored by Cartiva, Inc.
Cartiva’s implant is an organic polymer-based biomaterial to mimic biologic cartilage. The device, according to an FDA announcement, is to be indicated for treatment of degenerative and post-traumatic arthritis in the first metatarsophalangeal joint in the presence of good bone stock along with the following clinical conditions: hallux valgus or hallux limitus, hallux rigidus, and an unstable or painful metatarsophalangeal joint.
The FDA intends to make background material available to the public no later than two business days before the meeting.
The meeting will be held on Wednesday, April 20, 2016, from 8 a.m. to 6 p.m. at the Hilton Washington, DC/North, Salons A, B, C, and D, 620 Perry Pkwy., Gaithersburg, Maryland.
Last May we reported that the company submitted the final module for its PMA. The module covered the clinical results from the motion trial that evaluated the safety and effectiveness of Cartiva CI for the treatment of osteoarthritis at the base of the great toe.
The study involved the enrollment of 236 patients at 12 centers in Canada and the United Kingdom. The trial was designed to determine the safety and efficacy of Cartiva SCI in comparison to arthrodesis (fusion) for reducing the debilitating pain associated with osteoarthritis in the great toe. Patients were randomized 2:1 to either Cartiva SCI or arthrodesis. The primary endpoint for the trial was a composite evaluation of pain, function and safety.
Cartiva’s President and CEO Tim Patrick said, “This is the largest and most rigorous FDA trial ever completed for this clinical condition. We look forward to working with FDA to bring the first synthetic cartilage product to market.”
According to the company, Cartiva SCI is comprised of a proprietary polyvinyl alcohol (PVA) hydrogel designed to mimic natural cartilage. PVA is a synthetic polymer prepared by the hydrolysis of polyvinyl acetate and has been used in medical device applications for over 20 years. Cartiva customizes the PVA hydrogel to meet defined functional requirements. Cartiva officials state that the physical properties of Cartiva SCI, including the water content, compressive properties and low coefficient of friction, are similar to natural cartilage.

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3 takeaways from the AAOS about bundled payments for joint replacements

3 Takeaways from the Annual Meeting of AAOS (by Arundhati Parmar at MDDIonline)

How is bundled payment in joint replacement going to affect device makers? At AAOS, some conclusions could be reached.

A sea change is occurring in the way joint replacement surgery is performed and reimbursed in the U.S. On April 1, the Comprehensive Care for Joint Replacement Model that by which the Centers for Medicare and Medicaid Services will pay hospitals in 67 metropolitan statistical areas a fixed amount for the entire episode of joint replacement that stretches from 72 hours prior to surgery through 90 days after the procedure.
After attending the annual meeting of the American Academy of Orthopedic Surgeons, where the topic was discussed thoroughly, these three conclusions can be safely made about what the future holds.

New Kind of Innovation Will be Rewarded

In the medical device world overall, and in the orthopedics world in particular, there was one simple definition of innovation — launch a newer version of an existing product with more bells and whistles and charging a premium for it. In an exclusive interview with MD+DI at AAOS, Stryker CEO Kevin Lobo said those days are now over. He recalled that in October 2012 as part of an interview at the Cleveland Clinic he was asked when the company’s new knee was going to be launched.
“I said I don’t even have one in development” Lobo said. “There were 600 people in the audience that gasped — literally gasped — when I said that.”
But that didn’t mean that Stryker would stop innovating. In fact, that move away from the conventional definition of innovation led the Kalamazoo, MI, device maker to focus instead on improving the procedure of joint replacement and led to the acquisition of the Mako surgical system, the robotic platform that can now implant Stryker-made hips and knees.
“We decided to innovate on the procedure of joint replacement and not the product,” Lobo said.
Meanwhile, surgeons and hospitals are looking at process innovations and not necessarily product innovations.
For instance, can deviec makers partners with surgeons and hospitals to reduce the number of trays opened for a knee replacement. said Dr. Thomas Barber, an orthopedic surgeon based in Oakland, CA.
“Instead of 10 trays, can we do 2 trays,” he said noting that the reduction may be achieved by a change in packaging.
“I think that prosthetic/implant companies that are able to work with hospitals and physicians and partner with them to improve the care and improve the utilization of resources at the same time are the ones that are really going to profit from this,” said  “There will be more partnering with companies to look at ways to improve efficiency and productivity in the operating room to be able to do higher volumes in a shorter time and in a  safe manner.”
2. Implant Pricing Won’t Be Under Huge Pressure
Those who were worried that a bundled payment system would necessarily drive hospitals to ask for further price cuts from implant makers, can rest easy.
The general consensus is that hospitals will be more focused on reducing costs following the implant procedure in the hospital and will instead look at cutting costs in the recovery period.
“The way it’s set up the only place that the cost savings can come from is post-acute care, so it’s after hospital discharge,”
While hospitals may push device makers to reduce cost to give themselves a cushion should their costs to treat joint replacements is higher than the reimbursement target price set by CMS’ bundle, it’s not going to be significant.
Barber, however, noted that hospitals and payers are now negotiating commercial models modeled after CMS’ bundle that may very well include a desire to cut implant prices and reduce length of stay in the hospital.
3. Skilled Nursing Facilities Will Take a Hit 
Skilled nursing facilities that rely on patients being moved for rehab following joint replacement procedures are going to have a difficult time. While some hospitals have bought skilled nursing facilities, others still are standalone and may see their volume of joint replacement patients reduce tremendously.
One surgeon presenter at AAOS explained that in many cases these facilities order unneccearry diagnostic tests such as ultrasound or X-Ray that increase costs after hospital discharge. Bryan Springer, an orthopedic surgeon with OrthoCarolina, an academic orthopedics practice serving North Carolina and the Southeast said the group has been able to cut the number of skilled nursing facilities it works with to just 36 from 434 last year.
Device makers that sell supplies and equipment to such facilities need to pay heed to this new emerging economic reality when it comes to skilled nursing facilities, especially if their patient population is weighted heavily toward joint replacement patients.

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ConforMIS sues Smith & Nephew over patient-specific knee implants

ConforMIS sues Smith & Nephew, launches iTotal PS knee implant (press release)
Result of the ConforMIS-Wright Medical lawsuit ConforMIS Announces Settlement of Patent Infringement Lawsuits
ConforMIS leveled a lawsuit against Smith & Nephew this week, accusing the British orthopedics giant of trespassing on 8 patents covering the ConforMIS technology for patient-specific knee implants.
Bedford, Mass.-based ConforMIS also launched its iTotal PS, claiming it as the only customized posterior stabilized knee replacement system on the market.
The lawsuit against Smith & Nephew, filed in the U.S. District Court for Massachusetts, alleges that the London-based company’s Visionaire cutting guides, billed as “custom fit,” infringe the 8 ConforMIS patents. The Visionaire guides are used with off-the-shelf S&N implants, including the Journey II, Legion, and Genesis II devices, ConforMIS alleged.
The lawsuit accused Smith & Nephew of mis-promoting and inducing others to mispromote total knee arthroplasties using the Visionaire guides “as being ‘custom fit’ total-knee arthroplasty procedures, even though the end result uses a standard, off-the-shelf implant not customized for the patient.”
“Upon information and belief, this mispromotion has harmed ConforMIS by, on information and belief, diminishing its potential sales base and market share, and also diluting the strength of its patient-specific offering in the minds of the consuming public,” ConforMIS alleged.
ConforMIS also said the full launch of the iTotal PS follows a year-long limited release that saw the device implanted in more than 1,000 patients.
“The full launch of the iTotal PS nearly triples our addressable market. We believe this launch is our single biggest commercial opportunity to date,” founder, president & CEO Dr. Philipp Lang said in prepared remarks. “With iTotal PS, we have now greatly expanded the number of patients who will be candidates for our customized knee replacement implants. We are very excited to bring the benefits of customized knee replacements to surgeons who prefer a posterior-stabilized design. Since we initiated our limited launch of iTotal PS last year, the feedback from surgeons has been extremely positive.”
“The goal of a total knee replacement is a predictable outcome and a happy patient, every time. With off-the-shelf implants, most of the time we must make compromises,” added Dr. Jose Rodriguez of New York City’s Lenox Hill Hospital. “With ConforMIS, many of these compromises are eliminated because the implant fits anatomically. The reliability with which I can achieve a knee that fits better, and functions more naturally for my patients, is greater with iTotal PS than with standard, off-the-shelf implants.”

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Zimmer-Biomet acquires osseointegrated prosthesis technology for amputees

Zimmer Biomet Completes Acquisition of Ortho Transmission (HealthPointCapital)
press release here
Zimmer Biomet completed the acquisition of Ortho Transmission, LLC, a Colorado-based developer of skeletal implant technology for limb amputee patients.
Under the terms of the acquisition, Zimmer acquires Ortho Transmission’s transcutaneous osseous integrated skeletal implant technology which complements Zimmer’s ongoing collaboration with the U.S. Department of Defense (DOJ) for the development of a transcutaneous system for anchoring external prosthetic limbs to restore the mobility of amputee patients.
Transcutaneous systems are designed to eliminate a skin-to-socket interface, negate frequent prosthetic complications such as soft tissue irritation, sores, infections and joint pain, and can reduce the incremental energy the patient must exert in order to walk. Furthermore, direct skeletal attachment of a limb prosthesis with a transcutaneous device may enhance the patient’s ability to sense the position of the prosthetic.
This transaction provides Zimmer with novel limb replacement technology, aligning with the company’s broad-based focus on clinically relevant innovations. The company will leverage Ortho Transmission designs to commence a clinical trial. Management believes that Zimmer’s R&D capabilities and proprietary Trabecular Metal presents an ideal platform to accelerate the commercialization of such an prosthetic.

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DePuy's metal-on-metal hip linked with an increased risk of heart failure in men

Specific MoM hip implant linked with increased risk of heart failure in men
Men who underwent primary hip arthroplasty with a specific, conventional large-head metal-on-metal implant by a single manufacturer had almost double the risk of heart failure than men who received a metal-on-polyethylene implant after rates were adjusted for age, according to a presenter at the American Academy of Orthopaedic Surgeons Annual Meeting.
Although researchers found this correlation between the use of the ASR XL hip prosthesis (DePuy Synthes Joint Reconstruction) and the risk of heart failure in men, use of the implant did not have an effect on the heart failure rates of women who received the implant, said Stephen Graves, MD, at the meeting.
“As far as we are aware, this is the first cohort study to indicate an association with heart failure the use of the ASR XL prosthesis. The effect was evident in men. We were able to quantify the incidence in the study population, and the incidence was not small,” Graves said.
Using the Australian Government Department of Veterans’ Affairs health claim database, investigators included 2,115 men in the study. Of these primary hip replacement patients, 2,028 patients received a metal-on-polyethylene (MoP) implant and 87 patients received the ASR XL implant, he said.
Patients with the ASR XL implant had a significantly higher rate of hospitalization for heart failure. Graves and colleagues found the number needed to harm after 3 years for the ASR XL compared with the MoP implant was 10, meaning there was one additional heart failure hospitalization for every 10 patients treated with the ASR XL implant. – by Robert Linnehan 
Reference:
Graves S, et al. Paper #179. Presented at: American Academy of Orthopaedic Surgeons Annual Meeting; March 1-5, 2016; Orlando, Fla. 
Disclosure: Graves reports no relevant financial disclosures.

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