Biotronik touted long-term safety and efficacy data for its Orsiro drug-eluting stent yesterday at this year’s Transcatheter Cardiovascular Therapeutics meeting. Data from the Bioflow-II trial and the Bioflow-III registry demonstrated that Biotroniks’s device boasts strong safety and clinical performance at five years, the company reported. Get the full story at our sister site, Drug Delivery Business […]
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Reva, Biotronik tout safety data for their drug-eluting bioresorbable scaffolds
Despite the safety concerns plaguing Abbott‘s (NYSE:ABT) Absorb device, companies developing bioresorbable scaffolds are not discouraged. This week at the annual Transcatheter Cardiovascular Therapeutics Conference in Denver, a number of companies touted the safety data coming from clinical trials of their products. Among them were Reva Medical (ASX:RVA) and Biotronik – here’s an overview of that data. Get the full story at […]
European task force: Docs should favor drug-eluting stents over bioresorbable scaffolds
Physicians should not use bioresorbable scaffolds in place of current-generation drug-eluting stents, according to a report from the European Society of Cardiology and European Association of Percutaneous Cardiovascular Inventions. The ECS/EAPCI report says that as long as concerns remain about the increased risk of myocardial infarction and scaffold thrombosis linked with bioresorbable scaffolds, physicians should […]
Biotronik launches trial to test new coronary drug-eluting stent
Biotronik said yesterday that it began enrolling patients in a trial designed to assess the safety and efficacy of a new coronary drug-eluting stent in de novo coronary artery lesions. The Biovitesse polymer-free device combines ultra-thin struts with a new anti-proliferative limus drug designed to stop excessive cell growth, the company reported. Get the full story […]
ESC 2017 Roundup: Biotronik touts lowered mortality for AF patients treated with cath ablation
Biotronik today released results from the Castle-AF study exploring the use of catheter ablation to treat heart failure patients with atrial fibrillation, touting a 38% composite reduction in all-cause mortality and hospitalization for worsening heart failure. The 398-patient, 33-site study compared the results of catheter ablation treatment for AF in heart failure patients using implantable cardioverter […]
Biotronik’s Orsiro drug-eluting stent tops Abbott’s Xience in study
Biotronik said today that its Orsiro drug-eluting stent beat Abbott‘s (NYSE:ABT) Xience DES in a trial comparing the target lesion failure rates of both devices. The data, which were presented at the European Society of Cardiology’s ESC Congress and published by The Lancet, showed a 6.2% TLF rate at 12-months for patients treated with Orsiro compared to 9.6% […]
Getinge launches Biotronik’s Pulsar-18 SES in the US
Getinge (PINK:GETI B) said today it launched Biotronik‘s Pulsar-18 self-expanding stent in the US, operating as Biotronik’s distributor in the region for its portfolio of peripheral artery disease devices. Biotronik claims that the Pulsar-18, which won FDA clearance in March, is the only approved superficial femoral artery self-expanding stent with a 4-French delivery system, which it said […]
Biotronik launches Edora HF-T MRI-safe CRT-P, touts as smallest in US
Biotronik said today it launched its Edora HF-T magnetic resonance-conditional quadripolar cardiac resynchronization therapy pacemaker, touting it as the smallest device of its type available in the US. The German medical device company said the Edora HF-T QP has a volume of 15 cc, making it the smallest MR conditional CRT-P available in the US. The […]
Biotronik wins FDA nod for atrial lead-less Intica ICD line
Biotronik said today it won FDA approval for its Intica DX and Intica cardiac resynchronization therapy CRT-DX implantable cardioverter defibrillator systems and that it launched the devices in the US. The Berlin-based company touted that the Intica line of ICD devices are the 1st to not require an atrial lead, normally used to monitor electrical activity […]
Biotronik touts Pulsar-18 self expanding stent trial data
Biotronik today released results from the Bioflex-I pivotal clinical trial of its Pulsar-18 self-expanding stent designed for treating patients with peripheral artery disease, touting high rates of freedom from major adverse events and primary patency. The company claims the Pulsar-18, which won FDA clearance in March, is the only approved superficial femoral artery self-expanding stent with […]
Biotronik wins CE Mark for 3T scans with ProMRI pacers
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 […]