Articles tagged with 'Certification' | BIOTRONIK

BIOTRONIK - Archive (Certification)

2020
14
July
2020
| 09:55 Europe/Amsterdam
BIOTRONIK is proud to announce the availability of its next-generation balloon-expandable cobalt chromium iliac stent system, Dynetic®-35. When compared to leading competitors, the new peripheral stent has up to 14 times greater flexibility and up to...
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2019
18
December
2019
| 14:29 Europe/Amsterdam
  Medtech companies operating in Europe are getting ready for a busy year, with the end of the transition period for the European Union’s Medical Device Regulation (MDR) fast approaching. After the May 2020 deadline, all new medical devices must m...
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10
April
2019
| 00:00 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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14
March
2019
| 00:00 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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25
February
2019
| 00:00 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
14
September
2018
| 00:00 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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22
January
2018
| 00:00 Europe/Amsterdam
BIOTRONIK announced today market approval for its Orsiro1 coronary drug-eluting stent (Orsiro DES) by the Japanese Ministry of Health. This was supported by the positive 12-month outcomes of the BIOFLOW-IV clinical study which were presented at the 8...
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