David Hayes Biotronik has announced the appointment of David Hayes as chief medical officer. A press release reports that Hayes will oversee the development of the company’s cardiovascular solutions with a focus on advancing unique, proven innovations that help physicians and health systems deliver on their commitment to patient care. The press [...]
The Chinese National Medical Products Administration has granted market approval to Biotronik’s sirolimus-eluting Orsiro stent. A press release reports that the company expects to make the device, which has a biodegradable polymer, available to Chinese patients and physicians in the coming months. As the second largest drug-eluting stent market in the world, China is [...]
Biotronik has become the world’s first manufacturer to receive European Medical Device Regulation (MDR) certification for a Class III (highest risk) medical device. Following a successful conformity assessment, the company also obtained MDR certification for its quality management system. Class III medical devices represent the highest risk class of medical devices according to the [...]
The PK Papyrus covered coronary stent system (Biotronik) has been named a finalist in the 2019 Prix Galien USA Awards Ceremony for Best Medical Technology. PK Papyrus is designed to be used in emergency situations to create a physical barrier to seal perforated coronary arteries without the need for invasive surgery. In September 2018, [...]
BioMonitor III After receiving the CE mark, Biotronik has launched its next-generation injectable cardiac monitor (ICM)—BioMonitor III—onto the European market. A press release reports that the novel device is designed to help patients with irregular heart rhythms by documenting suspected arrhythmia or unexplained syncope with increased clarity. Aiming to improve the accuracy [...]