A 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 […]
Implants
Ocular Therapeutix doses first wet-AMD patient in implant trial
Ocular Therapeutix (NSDQ:OCUL) said today that it dosed the first patient in a study of its OTX-TKI tyrosine kinase inhibitor implant. The Phase I trial is slated to assess the bioresorbable device’s safety, durability and tolerability in people with wet age-related macular degeneration. Get the full story at our sister site, Drug Delivery Business News.
NeoTract’s UroLift system gains expanded insurance coverage
Teleflex (NYSE:TFX) subsidiary NeoTract said that two more health insurers have agreed to offer coverage for the company’s UroLift system or patients with an enlarged prostate. The Wayne, Penn.-based subsidiary of Teleflex said that major U.S. insurer Humana and the Motion Picture Industry Pension & Health Plans (MPI), administered by Anthem Blue Cross, have added UroLift to its […]
Check-Cap’s cancer screening capsule will have U.S. study
Check-Cap (NSDQ:CHEK) said its X-ray-enabled, colorectal cancer-screening capsule will have a pilot study in the United States. The Isfiya, Israel-based startup makes the C-Scan System, an ingestible capsule used to detect precancerous polyps without the need for laxatives or an invasive procedure. The C-Scan system uses an ultra-low dose X-ray capsule, an integrated positioning, control, and recording system, and proprietary […]
Brain tumor ‘monorail’ lands FDA breakthrough device nod
A “tumor monorail” that lures aggressive brain tumor cells to their death in an external container has won “breakthrough device” designation from FDA. The purpose of the device is not to destroy the glioblastoma tumor, but to halt its lethal spread, making the disease more of a condition to manage than a death sentence, according […]
Long-term stroke risk cut by carotid surgery or stenting
An international research team who compared the long-term effects of carotid artery surgery and stenting found the risk of stroke “remarkably low” even 10 years later, regardless of the type of procedure. Short-term stroke prevention was found to be better among surgery patients, but stenting technology has improved since these patients were implanted, said the study’s […]
New binoculars help cataract patients choose replacement lenses
Researchers in Spain have developed a device that simulates the improved vision that a cataract patient can have before corrective surgery even takes place. The scientists at the Spanish National Research Council’s Institute of Optics in Madrid compared the visual acuity obtained at different distances through a commercial trifocal lens (with focal points for close, intermediate […]
Swedish patient receives ‘dexterous, sentient’ prosthetic hand
A Swedish woman with a hand amputation has become the first recipient of an osseo-neuromuscular implant to control a dexterous hand prosthesis, according to Chalmers University of Technology in Gothenburg, Sweden. Surgeons placed titanium implants in the two forearm bones (radius and ulna), and extended electrodes to nerves and muscle to extract signals to control a […]
Number of cancer cases linked to breast implants soars
FDA said it has received reports of 457 unique cancer cases related to breast implants since 2010, including nine patient deaths. The agency identified those unique cases from a total of 660 adverse event reports in the U.S. from 2010 through September 2018, including 246 new adverse event reports since 2017. FDA began reporting on cases […]
Vectorious starts trial of implantable wireless heart monitor
Vectorious Medical Technologies said it has begun a first-in-human trial of its left atrial pressure monitoring device. Tel Aviv-based Vectorious is developing the V-Lap implantable wireless heart monitor, which is designed to monitor pressure in the heart’s left atrium. The Vector-HF trial will enroll up to 30 patients at six sites across Germany, Israel, Italy and the U.K. […]
Could this device replace pacemaker batteries?
The heart’s motion is so powerful that it can recharge lifesaving cardiac devices, according to new research from Dartmouth College. Engineers at Dartmouth’s Thayer School of Engineering developed a dime-sized device to convert the heart’s kinetic energy into electricity to power a wide range of implantable devices, according to the Hanover, N.H.-based college. Get the full […]