GI Dynamics touts results of U.K. study

GI DynamicsGI Dynamics (ASX:GID) said a retrospective study of its EndoBarrier device for patients with type 2 diabetes and obesity shows a significant reduction in HbA1c, weight, liver fat and cardiovascular disease (CVD) risks as well as a reduction in the need for insulin in some patients.

The EndoBarrier device is a plastic gut sleeve designed to prevent the absorption of nutrients from food as it exits the stomach and enters the intestinal tract, according to the Lexington, Mass.-based company.

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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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Smith & Nephew acquires Brainlab assets, teases next-gen robotic surgical platform

Smith & Nephew

Smith & Nephew (NYSE:SNN) said yesterday that it acquired Brainlab‘s orthopedic joint reconstruction business and teased the unveiling of a next-generation surgical robotics platform for later this year.

The London-based company said that its acquisition of Brainlab’s orthopaedic joint reconstruction business included its associated salesforce, which it plans to fold into its surgical robotics division. It added that it will look to install Brainlab’s hip software onto its currently-in-development Navio 7.0 handheld surgical system, which it plans to release during the second half of this year.

Along with the acquisition, Smith & Nephew said that it inked a collaborative development deal with Brainlab to develop additional applications for its advanced automation platform.

“The near term commercial opportunities with the innovation of our robotics platform and the integration of the Brainlab hip software are very compelling. Not to mention, the strong collaboration on design and development of next generation technology that will bring our customers more differentiated advanced surgical capabilities.  We’re excited to work together with Brainlab to bring the future of the digitally integrated O.R. to life and into the hands of surgeons world-wide,” prez Skip Kiil said in a prepared statement.

In the same release, the company said that it expects to complete development of its next-generation surgical robotics platform some time later this year, with a full commercial release in 2020. It teased that the new platform will have a dramatically reduced footprint and be able to be incorporated into the company’s sports medicine tower, and that the system will be faster than its still-in-development Navio 7.0.

Smith & Nephew added that its research & development program is looking to add augmented reality, stand-alone robotic arms and machine learning to the platform, and that it plans to open a new R&D and education center focused on robotics in Pittsburgh.

“Smith & Nephew is making a long-term commitment to bring together advanced technologies in robotics, digital surgery, and machine learning as well as augmented reality to empower surgeons and improve clinical outcomes. Over time these digital surgery and robotic assets will be deployed across all surgical specialities and healthcare settings where Smith & Nephew’s operates, starting with orthopaedic reconstruction and sports medicine,” CEO Namal Nawana said in a press release.

Yesterday, Smith & Nephew said that it agreed to put $660 million on the table to acquire Osiris Therapeutics (NSDQ:OSIR) and its regenerative medicine portfolio.

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Surgical staplers and staples linked to 41K+ injury or malfunction reports

FDA-logo-newFDA said today that it has received more than 41,000 adverse event reports — including 366 deaths — associated with surgical staplers and staples for internal use, and that it may require stricter product review of the devices.

The agency’s ongoing analysis of stapler- and internal-staple-related adverse event reports from Jan. 1, 2011 to March 31, 2018, also revealed more than 9,000 serious injuries and over 32,000 malfunctions. FDA attributed many of the problems to the staplers themselves because proper staple formation depends largely on proper function and use of the stapler.

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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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FDA warns against robot-assisted breast cancer surgeries

FDA-logo-newFDA has issued a warning against the use of surgical robots in mastectomies and other surgeries for the treatment or prevention of cancer.

The safety and effectiveness of surgical robots have not been established for use in mastectomies or for surgeries to prevent or treat breast and other cancers, according to the agency, which said it “encourages health care providers who use robotically-assisted surgical devices to have specialized training and practice in their use.”

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Vertos Medical’s spinal stenosis treatment wins CE mark

Vertos Medical said it has received CE mark approval for its lumbar spinal stenosis (LSS) treatment device kit.

Aliso Viejo, Calif.-based Vertos said its Mild device kit enables a minimally invasive procedure to remove the cause of stenosis through a portal the size of a baby aspirin. The procedure requires no stitches, general anesthesia, implants or overnight hospital stays, the company added.

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Apollo Endosurgery touts results of stomach-stapling study

 

Apollo Endosurgery’s OverStitch device

Apollo Endosurgery (NSDQ:APEN) has reported key data from 1,000 patients who underwent endoscopic gastroplasty using the company’s OverStitch device.

Published in the journal Gastrointestinal Endoscopy, the data include a mean total weight loss of 14.8%±8.5% at 18 months. Three months following surgery, the impact on obesity-related comorbidities included the complete remission of:

    • 13 of 17 cases of type 2 diabetes.
    • All 28 cases of hypertension.
    • 18 of 32 cases of dyslipidemia.

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