Biotronik announced today that it won FDA breakthrough device designation for its Freesolve below-the-knee resorbable magnesium scaffold. The company designed the Freesolve BTK RMS for individuals with chronic limb-threatening ischemia (CLTI). It recently launched the scaffold in Europe after receiving CE mark for treating coronary artery lesions. Lake Oswego, Oregon-based Biotronik based its system on the […]
Biotronik
Biotronik, IMDS launch new coronary microcatheter
Biotronik announced that it launched the Micro Rx catheter for enhancing guidewire support during percutaneous coronary interventions (PCI). Interventional Medical Device Solutions (IMDS) manufactures Micro Rx and Biotronik has exclusive distribution rights. Micro Rx marks the fourth IMDS product brought to the U.S. by Biotronik, joining the NHancer Rx, TrapIT and ReCross catheters. The Micro […]
Biotronik announces 100,000th implant of ICDs with AFib monitoring
Biotronik announced today that it hit 100,000 implanted single-lead implantable cardioverter defibrillators (ICDs) with DX Technology. DX Technology enables direct atrial sensing for AFib detection and monitoring. Since its introduction in 2009, clinicians in more than 80 countries around the world have used DX ICDs. The technology offers reliable, timely information about atrial arrhythmias and […]
Biotronik has positive data for its spinal cord stimulation tech
Biotronik today announced positive results from a clinical trial for its Neuro Prospera spinal cord stimulation (SCS) system. The BENEFIT-02 trial evaluates the Resonance multiphase stimulating paradigm used in the Neuro Prospera system. It looked at the safety and effectiveness of the stimulator in treating patients with chronic pain. Contrary to other currently available SCS […]
Biotronik announces first U.S. implant of next-gen pacemaker
Biotronik today announced the first U.S. implantation of its new, next-generation Amvia Edge pacemaker system. The FDA approved the Biotronik portfolio of Amvia Edge pacemakers last month. Dr. Raul Weiss completed the procedure at Mount Sinai Medical Center in Miami, Florida. “I was very pleased to have been a part of the first implant of […]
FDA approves next-gen family of pacemakers from Biotronik
Biotronik announced today that the FDA approved its portfolio of Amvia Edge pacemakers and cardiac resynchronization therapy pacemaker (CRT-P). Lake Oswego, Oregon-based Biotronik designed Amvia Edge as the market’s smallest single-chamber MR conditional pacemaker. It offers a set of patient-centric solutions coupled with automated workflow efficiency. The pacemakers feature Biotronik’s proprietary MRI Guard 24/7 technology. […]
Philips, Biotronik partner to expand care for out-of-hospital cardiology labs
Philips today announced a new partnership with Biotronik. The companies teamed up to expand the range of cardiovascular devices available for Philips SymphonySuite customers. Biotronik develops products and services for treating cardiovascular and endovascular diseases. Philips designed its SymphonySuite for opening and expanding cardiovascular office-based labs OBLs and ambulatory surgery centers (ASCs). The Amsterdam-based medtech […]
FDA approves spinal cord stimulation system from Biotronik
Biotronik announced today that it received FDA approval for its Prospera spinal cord stimulation (SCS) system. The regulatory nod marks the launch of the Lake Oswego, Oregon-based company’s new Biotronik Neuro business segment. Propsera features Resonance, a multiphase stimulation paradigm. It pairs with Embrace One, a patient-centric care model that provides automatic, objective, daily remote […]
FDA approves Biotronik’s self-expanding stent system
Biotronik announced today that it received FDA approval for its Pulsar-18 T3 peripheral self-expanding stent system. Pulsar-18 T3 combines a 4-French low-profile delivery system with a tri-axial system with a braided shaft design and thin struts with low chronic outward force (COF), creating an improved implantation procedure for endovascular treatments. According to a news release, […]
Biotronik reaches $12.95M settlement with DOJ over improper payment allegations
Biotronik today agreed to pay a $12.95 million settlement with the U.S. Justice Dept. (DOJ) to resolve allegations that it violated the False Claims Act. DOJ alleged that the cardiac device maker violated the False Claims Act by causing the submission of false claims to Medicare and Medicaid by paying kickbacks to physicians to induce […]
FDA approves Biotronik’s programmer for implanted cardiac rhythm management devices
Biotronik announced today that the FDA approved its Renamic Neo programmer for implanted cardiac rhythm management devices. Lake Oswego, Oregon-based Biotronik designed its Renamic Neo programmer for implanted devices, including ICDs, pacemakers and implantable cardiac monitors. According to a news release, Renamic Neo offers LifeSupport for clinicians to share the programmer screen with or grant […]