Surmodics (Nasdaq:SRDX) announced today that it received FDA 510(k) clearance for its Pounce XL thrombectomy system. The FDA indicated Pounce XL for the non-surgical removal of thrombi and emboli from the peripheral arterial vasculature in vessels 5.5–10 mm in diameter. That makes it suitable for iliac, femoral, and other arteries within this range. Pounce XL […]
nitinol
Synchron reports positive results from Command study of its BCI system
Brain-computer interface (BCI) developer Synchron today said there were no serious adverse events in its 12-month Command study, which also showed reliable performance of the Stentrode implant. Synchron won FDA breakthrough device designation for the endovascular brain implant in 2020. The Command study is the first investigational device exemption (IDE) trial of a permanently implanted […]
CereVasc wins FDA breakthrough nod for eShunt system
CereVasc announced today that it received FDA breakthrough device designation for its eShunt system for treating normal pressure hydrocephalus (NPH). The company said data generated during pilot clinical studies of the device supported the breakthrough device designation. This designation enables priority review and enhanced communication with the FDA during the clinical trial and premarket review […]
Johnson & Johnson to buy heart failure treatment maker V-Wave for up to $1.7B
Johnson & Johnson announced today that it agreed to acquire interatrial shunt maker V-Wave for up to $1.7 billion. The medtech giant says the planned acquisition extends its position as a leader in addressing cardiovascular disease. V-Wave develops cardiovascular implant technology that specifically targets heart failure with reduced ejection fraction (HFrEF). The company designed its […]
SMT’s TAVR wins CE Mark for aortic stenosis
Sahajanand Medical Technology (SMT) announced today that its Hydra TAVR device has received the CE Mark for the treatment of severe aortic stenosis. The Hydra aortic valve is a self-expandable, nitinol-based, supra annular aortic system with a mechanism for recapturing the valve during deployment, according to Mumbai, India-based SMT. This property helps in precise placement […]
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 […]
Boston Sci giving lift to new erectile dysfunction device
Want to put some lead in your pencil? Try nitinol instead. The wonder metal—a nickel-titanium alloy with heat-activated shape memory—has proved essential for Wisconsin and Illinois researchers building what British tabloids are calling a “bionic penis.” Chuckles aside, the proposed implant has enough potential advantages over existing erectile dysfunction treatment implants that Boston Scientific officials […]
