Can a lifetime guarantee boost value-based care?

Cheryl Bednar, 54, of Laflin, Penn., suffered from chronic pain from hip deterioration until Geisinger Dr. James Murphy performed a hip replacement in February 2018 and offered the lifetime guarantee. (Image from Geisinger)

Swiss orthopedics company Medacta International and Geisinger Health System have said they will pilot a lifetime guarantee program for knee replacement surgeries.

The program will cover full costs for screened Geisinger Health Plan members who receive knee replacement surgery while also ensuring reimbursement for any associated future care the patients may incur throughout their lifetimes. Medacta and Geisinger will share the costs of the implant and associated hospital fees while patients remain on the Geisinger Health Plan and are treated by Geisinger providers.

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Think Surgical, United Orthopedic join forces for global sales

Think Surgical and United Orthopedic have announced a global joint marketing agreement of Think’s Active robotic system and United’s U2 knee system.

Think’s Active robotic system consists of a 3D pre-surgical planning workstation and its computer-assisted Active robot. Its use in total knee arthroplasty is the subject of an FDA investigational device exemption study, with clearance anticipated in 2019. The system’s core technology has been used in thousands of total hip and knee replacements worldwide, according to Fremont, Calif.-based Think.

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FDA ramps up scrutiny of materials in medical devices

(Image by Michael Longmire on Unsplash)

The FDA said today it has begun more closely scrutinizing the roles of certain materials associated with harm to patients who have breast implants, nitinol-containing devices, metal-on-metal hip implants and devices made from animal-derived substances.

It’s the latest in a series of statements the agency has issued following increasingly harsh public criticism of its efforts to regulate the medical device industry. In the past year, Netflix’s documentary “The Bleeding Edge” and the International Consortium of Investigative Journalists’ “The Implant Files” series ripped the agency and the industry over patient injuries attributed to faulty devices. The FDA has been particularly faulted for its 510(k) clearance pathway, under which it allows devices that are similar to previously approved technology to undergo a less strenuous review before they can be sold.

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10+ orthopedic products from AAOS 2019 you need to know

Attendees line up to register for the American Academy of Orthopaedic Surgeons annual meeting in Las Vegas this week. More than 30,000 people were expected. (Image from AAOS)

The American Academy of Orthopaedic Surgeons (AAOS) annual meeting in Las Vegas is abuzz about robotics, according to industry analysts from SVB Leerink.

While the SVB Leerink analysts termed Stryker’s  (NYSE:SYK) Mako platform “best-in-class,” it’s an expanding category. Other major orthopedics companies are using this week’s AAOS meeting to introduce new offerings or tout updates to existing ones.

Johnson & Johnson (NYSE:JNJ), for example, said it plans to debut its Orthotaxy total knee system in 2020, with spine, hip and eventually shoulder indications likely to follow. J&J bought the French robot-assisted surgery startup in 2018, and didn’t have any photos of the prototype to share. But the analysts said it attaches to the patient table and includes a saw/bone cutting capability, like Mako. Unlike Mako, it will not have haptic capability. Rather, it gets the surgeon locked into a cutting plane and preserves the surgeon’s control of the saw (side to side and front to back) on that plane.

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Miach Orthopaedics touts results of two-year study on ACL repair

Miach Orthopaedics said that a study of its bio-engineered implant for autograft anterior cruciate ligament (ACL) repair revealed results similar to those achieved by traditional ACL repair surgeries two years post-procedure.

The non-randomized, two-arm study conducted at Boston Children’s Hospital enrolled 10 patients treated with Miach Orthopaedics’ bridging scaffold-enhanced ACL repair (BEAR) implant with hamstring autograft ACL reconstruction and was conducted under an FDA Investigational Device Exemption. The BEAR implant was designed to be surgically placed between the torn ACL ends at the time of repair, and to hold a small amount of the patient’s blood in the wound site. This provides a scaffold that allows the torn ends of the ACL to heal back together.

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FDA issues ‘leap-frog’ guidance on brain/computer interfaces

A researcher instructs a patient on how to move an artificial hand using a brain/computer interface device.

FDA has issued draft guidance for developers of devices to help amputees and people with paralysis regain mobility or their sense of touch.

FDA defines brain/computer interface (BCI) devices as neuroprostheses that interface with the central or peripheral nervous system to restore lost motor or sensory capabilities. The guidance proposes that non-clinical device testing can be used to demonstrate that potential risks have been mitigated before beginning a clinical study. It also provides detailed recommendations on preparing to submit an application for an investigational device exemption.

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Cultivate(MD) buys into magnesium alloy developer

Genesis Innovation Group's Cultivate(MD)Genesis Innovation Group‘s Cultivate(MD) Capital Fund II said that it has invested in Magnesium Development Company (MDC), a firm with a breakthrough magnesium (Mg) alloy technology for orthopedic use.

MDC designed its technology to combine the strength and handling properties of metal with complete, controllable absorption. Its magnesium alloy may be used in multiple applications to provide appropriate strength for a given indication while not interfering with imaging or creating the need for future hardware removal procedures, according to a statement from Genesis. The Holland, Mich.-based company’s devices will include interference screws for anterior cruciate ligament (ACL) repair, sports medicine anchors, various plates, screws, and wires addressing foot and ankle procedures, as well as trauma applications.

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FDA slaps Class 1 designation on corneal implant recall

FDA has upgraded a recall of the Raindrop corneal inlay to Class I, the most serious designation.

Developed by the now-defunct ReVision Optics, the inlay was designed to treat presbyopia. But 75% of patients in a post-approval surveillance study developed corneal hazing. ReVision closed its doors last year; RVO 2.0, doing business as Optics Medical, now owns the Raindrop device and initiated the recall in November, advising customers not to implant the inlay devices. Raindrop is banned from distribution in the U.S., according to FDA.

Lake Forest, Calif.-based ReVision won pre-market approval from the FDA in June 2016 for the Raindrop inlay to treat presbyopia. The device is a microscopic hydrogel inlay placed in the cornea of the patient’s non-dominant eye during a 10-minute procedure to reshape the anterior curvature of the cornea.

The recall covers 2,869 devices distributed between August 2016 and March 2018. FDA issued a safety communication in October, citing a five-year, 150-patient post-approval study. Interim data showed a 42% rate of central corneal haze (63/150), a 75% rate of any corneal haze (113/150) and a 23.3% rate of device removal to date (35/150); of those, some 31% (11/35) had their Raindrop implant removed due to corneal haze, according to the agency.

FDA had initially cleared Raindrop based on two-year clinical data showing a 16.1% rate of central corneal haze (60 of 373 patients), a 1.1% rate of patients with two or more lines of loss in vision (4/373) and a device removal rate of 6.4% (24/373); some 29% of those removals were due to corneal haze (7/24), the agency said.

FDA said it began working with Optics Medical last year to remove the product from the market.

 

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Cultivate(MD) buys into Embody and its ortho injury implant

Genesis Innovation Group's Cultivate(MD)Genesis Innovation Group‘s Cultivate(MD) Capital Fund II said that it has invested in Embody, a startup that has developed a collagen-based microfiber implant designed for use in Achilles’ and rotator cuff repairs.

Embody (Norfolk, Va.) based its Tapestry implant on research on collagen-accelerating recellularization by growing new aligned tissue over surgical repairs. The company previously received $12.1 million in DARPA funding and a research and development contract that has funded product development. Cultivate(MD) is the leader in the new $3.6M raise that is earmarked for pre-launch and pre-commercial activities for Tapestry.

“Embody technology is built on an incredible body of research and development which utilizes powerful manufacturing technology to produce soft-tissue augmentation products that provide optimal characteristics for growth of tissue,” said Genesis Innovation Group CEO Rob Ball in a prepared statement. “They’ve developed a truly unique platform that will deliver product innovation for years to come.”

“We were very impressed by (Emody CEO Jeff Conroy) and his team throughout the diligence process. They provided significant histology and testing data, vetted regulatory pathways and had performed extensive research on intellectual property matters,” added Matt Ahearn, Genesis’ VP of finance and operations. “They’ve made tremendous progress on their manufacturing capabilities which provide capacity to support Embody’s first 36 months of commercial activity.”

Embody said it expects future studies will be conducted on scarring and the speed of post-operative rehabilitation. Ball will join Embody’s board of directors.

 

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Study finds fault with ICD leads that Abbott inherited from St. Jude Medical

AbbottA review of FDA adverse event reports has revealed that some Abbott (NYSE:ABT) implantable cardioverter defibrillator (ICD) leads were much more likely than those made by Boston Scientific or Medtronic to fail due to internal insulation breaches (IBR).

Researchers at the Minneapolis Heart Institute Foundation combed through the FDA MAUDE database from 2008 to 2018 for reports of IBR breaches and other ICD failures. They found that insulation breaches led to 93% of Abbott’s (formerly St. Jude Medical’s) Durata pacemaker lead failures. All 11 failures to treat ventricular tachycardia/ventricular fibrillation were caused by high-voltage shorts between the proximal and distal right ventricular coil cables or sensing conductor. Testing showed low values of high-voltage impedance in three of the leads after a shock or an aborted shock or by an alert, they wrote in an article published in the journal Heart Rhythm.

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