Biotronik said today it won CE Mark approval in the European Union for 3 Tesla full-body scans with its latest range of MR conditional pacemakers featuring its ProMRI technology. The new clearance covers single and dual chamber pacemakers from the Edora, Evity and Enitra series during ultra-high field MRI scans. The approval makes it possible to […]
Biotronik
Biotronik wins FDA nod for CRT-D Multi-Pole Pacing tech
Biotronik said today it won FDA approval for its MultiPole Pacing technology designed for its cardiac resynchronization therapy defibrillator systems. The MPP technology is designed to treat the 40% of heart failure patients who are initially non-responsive to CRT by enabling the left ventricle to be paced twice per cardiac cycle, the Berlin, Germany-based company […]
Biotronik launches, touts smallest MRI-safe defib leads on market
Biotronik said today it launched its Plexa ProMRI 7.8 French MR conditional tachycardia lead in the US, touting it as the smallest lead of it’s kind on the market. The company said it won FDA approval for the leads in February 1, indicated for use with implantable cardioverter defibrillators and heart failure devices. “This is another […]
Biotronik touts doctors’ survey responses for Magmaris drug-eluting scaffold
Biotronik touted data today from its Magnesium 1,000 program, which provided doctors with an early post-market opportunity to evaluate the company’s new resorbable Magmaris magnesium scaffold. More than 98% of physicians reported that the scaffolds successfully deployed, according to the data, and that it performed well compared to the leading polymeric scaffold, Biotronik said. The program […]
Biotronik touts Orsiro data at Japanese conference
Biotronik touted data today from the BioFlow-IV study of its Orsiro hybrid drug-eluting stent at this year’s Japan Circulation Society congress. The company’s study enrolled 579 patients with de novo coronary lesions and randomized them to receive either the Orsiro stent or Xience stent. After 12 months, the researchers confirmed non-inferiority of its stent, based […]
FDA clears Biotronik’s Pro-Kinetic Energy cobalt chromium stent
Biotronik said today it won FDA approval for its Pro-Kinetic Energy cobalt chromium coronary stent system, with indication for use in patients with arterial blockages between 2.25 and 4mm in diameter and lesion length up to 31 mm. The Pro-Kinetic Energy stent system is designed to imProve coronary luminal diameter in patients with new or recurring […]
Biotronik receives FDA warning on Berlin plant; launches Ilivia CRT-Ds
UPDATED Feb. 1, 2017, with comment from Biotronik. The FDA this week released a warning letter it sent to Biotronik over issues it identified during an inspection of its facilities in Berlin, shortly after the company announced the launch of its Ilivia cardiac resynchronization therapy devices. In the letter, the federal watchdog referenced 6 specific violations […]
Biotronik launches BioMonitor 2 subcutaneous heart monitor trial
Biotronik said today it enrolled the 1st patients in the BioInsight clinical study of its BioMonitor 2 heart monitor, which looks to investigate the feasibility implanting the BioMonitor 2 in office settings. The BioMonitor 2 device is designed for remote monitoring of patients with atrial fibrillation, syncope, bradycardia and tachychardia, Biotronik said. The device uses Biotronik’s ProMRI […]
Veith 2016 Roundup: Stent grafts take center stage
Medtronic touts Endurant stent graft data from Engage study Medtronic (NYSE:MDT) touted data from a series of sub-group analyses from the 10-year 1,200-patient Engage study of its Endurant II and Endurant IIs stent grafts for treating abdominal aortic aneurysms last week at the annual Veith Symposium on vascular disease. First-time results from a review of […]
Biotronik launches high energy Inventra HF-T ICD
Biotronik said today it launched the “ultra-high” energy Inventra HF-T, touting it as the 1st and only implantable cardioverter defibrillator available to deliver 42 joules in the 1st shock. The new addition to Biotronik’s line includes the company’s DX system, which offers dual-chamber diagnostics with a single specialized defibrillator lead. “For an increasing number of patients […]
Biotronik touts dual drug-coated balloon-stent therapy for lower-limb disease
Biotronik today released data from studies of its Pulsar-18 bare metal self-expanding stent and Passeo-18 Lux drug-coated ballon, touting high rates or primary patency and freedom from target lesion revascularization in both stand-alone and combined therapy procedures in lower-limb interventions. Data from the studies was presented yesterday at the Cardiovascular and Interventional Radiological Society of […]