Articles tagged with 'Certification' | BIOTRONIK

BIOTRONIK - Archive (Certification)

2019
July
08,
2019
| 13:48 PM Europe/Amsterdam
BIOTRONIK today announced FDA clearance of the BIOMONITOR III injectable cardiac monitor (ICM). BIOMONITOR III is designed to document suspected arrhythmia or unexplained syncope with increased clarity, enabling fast diagnosis and appropriate treatme...
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April
10,
2019
| 14:05 PM Europe/Amsterdam
BIOTRONIK today announced the United States (US) commercial launch of the PK Papyrus® covered coronary stent system for use in the emergency treatment of acute coronary perforations.1,2 More than 800,000 percutaneous coronary intervention procedur...
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March
14,
2019
| 14:11 PM Europe/Amsterdam
BIOTRONIK today announced FDA approval of the Acticor and Rivacor high-voltage cardiac rhythm management (CRM) device families for treatment of patients with cardiac arrhythmias. The six new tachycardia solutions include Rivacor VR-T, Rivacor DR-T, R...
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February
25,
2019
| 14:44 PM Europe/Amsterdam
BIOTRONIK today announced FDA approval of the Orsiro drug-eluting stent (DES) system. Orsiro is the first and only ultrathin DES to outperform the clinical standard, Xience.1,2 Orsiro received CE marking in 2011 and has been used to treat more than o...
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2018
September
14,
2018
| 19:30 PM Europe/Amsterdam
BIOTRONIK today announced the FDA approval of the PK Papyrus covered coronary stent system under Humanitarian Device Exemption for use in the emergency treatment of acute coronary perforations.1,2 PK Papyrus received CE marking in 2013. Built on B...
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