The recent shutdown of a Sterigenics medical device sterilization plant in Willowbrook, Ill. has affected medtech giants such as Becton Dickinson (NYSE:BDX), Boston Scientific (NYSE:BSX), Medtronic (NYSE:MDT), Smith & Nephew (NYSE:SNN) and Stryker (NYSE:SYK), according to an FDA list of devices processed at the sterilization plant. Medium-sized and smaller firms, including Teleflex (NYSE:TFX), Arthrex and ArthroCare also had devices processed there. The Willowbrook plant sterilized 594 types of devices, including sutures, clamps, […]
Surgical
Ethicon seeks data on Neuwave liver ablations
Johnson & Johnson (NYSE:JNJ) subsidiary Ethicon said it has launched a global registry to collect and analyze real-world data on patients with soft tissue liver lesions ablated with the company’s Neuwave microwave ablation system. The multicenter, observational registry will follow approximately 1,500 patients worldwide for five years from the date of their first liver […]
Titan Medical, Teleflex ink collab robotic ligation dev deal
Titan Medical (NSDQ:TMDI) said today that it inked a collaborative development deal with Teleflex (NYSE:TFX) to integrate its polymer ligation technology into Titan’s Sport single-port robotic surgical platform. Toronto-based Titan Medical said that Wayne, Penn.-based Teleflex’s polymer ligation system is intended for vessel sealing and includes an enhanced clip security feature that has been previously used in […]
GI Dynamics touts results of U.K. study
GI 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 […]
FDA ramps up scrutiny of materials in medical devices
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 […]
10 orthopedic products from AAOS 2019 you need to know
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 […]
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 […]
Smith & Nephew acquires Brainlab assets, teases next-gen robotic surgical platform
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 […]
Surgical staplers and staples linked to 41K+ injury or malfunction reports
FDA 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 […]
Cultivate(MD) buys into Embody and its ortho injury implant
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 […]
FDA warns against robot-assisted breast cancer surgeries
FDA 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 […]