An FDA advisory panel yesterday recommended deep, long-term surveillance of the leadless pacemakers being developed by the 4 leading companies in the cardiac rhythm management space. Medtronic (NYSE:MDT), St. Jude Medical (NYSE:STJ), Boston Scientific (NYSE:BSX) and Biotronik are all developing versions of a leadless pacemaker designed to be implanted directly into the heart’s right ventricle, eschewing the need […]
Biotronik
Biotronik claims Orsiro stent beats Abbott’s Xience in heart attack subgroup
Biotronik today touted study results showing that its hybrid Orsiro drug-eluting stent may have the edge on the Xience Prime and Xience Xpedition stents made by Abbott (NYSE:ABT) in patients with a certain kind of heart attack.* Published in the journal EuroIntervention, a sub-analysis from the Bioscience trial of 407 patients with ST-segment elevation myocardial infarctions showed that the rate […]
Biotronik wins Japanese clearance for MR-safe Itrevia CRT-D
Biotronik said today it won Japanese regulatory clearance for its Itrevia 7 HF-T cardiac resynchronization therapy defibrillator, now approved for full-body MRI-scanning. With the clearance, physicians in Japan are now cleared to perform MRI scans at 1.5 tesla strength on patients implanted with the Itrevia CRT-D. “In addition to having indispensable diagnostic information in the field […]
Maquet & Biotronik ink distribution deal for peripheral devices
Getinge‘s (PINK:GETI B) medical subsidiary Maquet Medical Systems USA said today it is partnering with Biotronik to distribute the German firms peripheral vascular devices in the U.S. Maquet will distribute “a range” of Biotronik products designed to treat peripheral artery disease, including its Astron iliac self-expanding stent, Passeo percutaneous transluminal angioplasty balloon products and the […]
Biotronik wins CE Mark for MRI-safe Ilivia ICD & CRT-Ds
Biotronik said today it won CE Mark approval for its Ilivia ICD and CRT-Ds, which feature the company’s ProMRI and MRI AutoDetect technology to make them compatible with magnetic resonance imaging systems. Biotronik’s MRI AutoDetect feature allows the device to be set to automatically recognize MRIs and switch into MRI mode without having to directly […]
Biotronik expands DCB line with CE Mark for Passeo-18 Lux
Biotronik said today it won CE Mark approval in the European Union for smaller sizes of its Passeo-18 Lux drug-coated balloon designed for treating peripheral arterial disease, specifically de novo and restenotic lesions in the infrainguinal arteries. The device is now cleared in 2 mm and 2.5 mm sizes to facilitate treatment of below-the-knee arteries. Approval […]
FDA clears Biotronik’s full-body MRI-safe Iperia ICDs
Biotronik said last week it won FDA premarket approval for its Iperia family of magnetic resonance imaging-compatible implantable cardioverter defibrillators. The approval includes Biotronik’s Iperia DR-T DF-1 and DF4 configurations, the Iperia DX and Iperia ProMRI DX, the company said. “Our goal is to integrate ProMRI technology across our entire line of implantable systems, and […]
Biotronik wins 2 FDA clearances: Iperia MRI-safe ICD and Astron peripheral stent
Biotronik said today it won FDA premarket approval for its latest family of MRI compatible implantable cardioverter defibrillators and won another premarket approval for its Astron peripheral self-expanding stent system. The company’s ProMRI ICD portfolio approval includes the DF-1 and DF4 configured Iperia DR-T, the Iperia Dx hybrid ICD and the Inventra ProMRI Dx which […]
Biotronik launches CLS-equipped pacer trial for treating syncope
Biotronik said today it enrolled the 1st patients in its BioSync CLS trial looking to examine whether its closed loop stimulation-equipped pacemakers can prevent syncope. Recurrent syncope, or fainting, is often proceeded by a drop in blood pressure or heart rate, so patients diagnosed with the disorder are often indicated for pacemakers, Biotronik said. “While not fatal, […]
Patent board hands St. Jude Medical a win over patent troll
A U.S. patent board last week handed a win over a patent troll to St. Jude Medical (NYSE:STJ), ruling that several claims in a patent owned by Atlas IP LLC are unpatentable. Atlas, a so-called “non-practicing entity,” was pursuing infringement lawsuits against St. Jude, cross-town rival Medtronic (NYSE:MDT), Boston Scientific (NYSE:BSX) and Biotronik. In a Dec. 3 ruling, the U.S. Patent […]
Biotronik’s Eluna 8 MRI-safe pacer hits the market in Japan
Biotronik yesterday said that its Eluna 8 MRI-safe pacemaker hit the market in Japan, for 1.5-tesla full-body scans and conditional 3T scans. “Heart disease is the 2nd-most prominent cause of mortality in Japan and we at Biotronik are committed to saving lives of those affected by it. By opening up full-body MRI scanning possibilities for device […]