A Philadelphia cardiologist has written a newspaper column questioning the efficacy and cost of Boston Scientific’s Watchman device for stroke prevention. The Watchman left atrial appendage closure device is designed to prevent blood clots that form in the heart’s left atrial appendage from reaching the brain. Boston Scientific (NYSE:BSX) markets it as an alternative to blood-thinning […]
Implants
How one medtech company is working on solving the data dilemma
The electronic medical record was designed to better track patient care, but it has had unintended consequences. Physicians are bombarded with digital patient information all day long, reducing their patient eye-to-eye interactions and adding hours to their workday. A 2016 American Medical Association study found that physicians spent about two hours on electronic health record […]
Study: Boston Sci’s Watchman cheaper than drugs long-term
Updated to include comments from the principal investigator. A new study has found that use of the Boston Scientific (NYSE:BSX) Watchman left atrial appendage closure (LAAC) device to treat atrial fibrillation costs less than existing and novel anticoagulant drugs over five years. Researchers conducted the analysis using an Excel-based simulation model developed to assess the […]
First patients implanted with Exactech’s non-cemented Truliant knee
Exactech (NSDQ:EXAC) today announced the successful first surgeries involving its Truliant Porous knee implant. Truliant Porous is a non-cemented implant system that Exactech said is designed for reproducibility and efficiency in total knee arthroplasty. Truliant Porous is designed to reduce micromotion and aid potential bony in-growth, according to the company. The system features a unique […]
FDA clears Life Spine’s surgical spacer system
Life Spine said that the FDA has granted 510(k) market clearance for the company’s Prolift lateral expandable spacer system. The system features minimal insertion height and controlled, in situ expansion, which are critical components in a minimally invasive expandable lateral interbody fusion procedure, according to the Huntley, Ill.-based company. “The Prolift lateral expandable spacer system […]
Report: N.J. and Texas law firms accused of charging excessive fees in pelvic mesh cases
Several law firms in New Jersey and Texas are accused of legal malpractice and charging excessive fees in transvaginal mesh cases, according to a report in the New Jersey Law Journal. The class action lawsuit, filed in Bergen County, N.J., claims that the Nagel Rice law firm (Roseland, N.J.) and the Potts Law Firm (Houston, […]
Meril Life Sciences’ MyVal TAVR wins CE Mark
Indian medtech maker Meril Life Sciences said it has won the CE Mark for its MyVal-THV system, a transcatheter aortic valve replacement (TAVR) developed exclusively in India. The MyVal device is balloon-expandable and employs a hybrid honeycomb cell design. The upper, open cells were designed to ensure un-jailing of coronary ostia, and the closed, lower cells […]
Abbott touts real-world CGM data at diabetes conference
Abbott (NYSE:ABT) said today that new data show its FreeStyle Libre continuous glucose monitoring (CGM) system significantly reduces hemoglobin A1c (HbA1c) levels in certain adults with type 2 diabetes. Presented as a late-breaker at American Diabetes Association (ADA) annual conference in San Francisco, the data represent what Abbott termed the first evaluation of real-world evidence from […]
Canada bans Allergan Biocell breast implants
Health Canada has suspended sales of Allergan’s Biocell breast implants due to a higher incidence of a rare breast cancer in patients with macro-textured breast implants than other implants. The Allergan (NYSE: AGN) Biocell breast implants are the only macro-textured implants available in Canada. The regulatory agency instituted the ban based on the results of a 2017 safety […]
Report: J&J faces uphill battle in $20 million pelvic mesh appeal
Johnson & Johnson (NYSE:JNJ) is appealing a $20 million verdict in a 2018 Indiana pelvic mesh trial, but a federal appeals court panel pushed back against the device maker’s argument this week, according to a published report. J&J’s Ethicon subsidiary claims it was wrongly barred from presenting evidence from the FDA saying that its Prolift pelvic […]
FDA slaps Orchid Orthopedic with warning letter
The FDA has issued a warning letter to Orchid Orthopedic Solutions, a major design and manufacturing outsourcer in the orthopedic medical device space, for alleged violations including unsanitary water used to clean implants. The letter, dated May 13 and released today, says the company’s facility at 23149 Commerce St., Farmington Hills, Mich. failed to adequately […]