Medtronic receives US FDA Breakthrough Device Designation for complex EVAR device

Source: BIBA MedTech Aortic Segmentation Monitor The US Food and Drug Administration (FDA) has granted Breakthrough Device Designation to Medtronic for its novel Valiant thoracoabdominal aneurysm (TAAA) stent graft. A press release reports that the device is designed to offer an off-the-shelf solution for complex endovascular aneurysm repair (EVAR) procedures, adding that [...]

Aortic Insights Q1 2019

Source: BIBA MedTech Aortic Segmentation Monitor Aortic Insights is a quarterly report that provides in-depth analysis of the key findings of the Aortic Segmentation Monitor (BIBA MedTech Insights). Each quarter, the monitor tracks aortic procedures performed in Western Europe. It looks at the segment treated (infrarenal, complex, and thoracic), type of procedure [...]

2019-11-12T11:53:13+00:00October 8th, 2019|Tags: , |

AtriCure agrees to buy LARIAT developer SentreHEART

LARIAT AtriCure has entered into a definitive agreement to acquire SentreHEART, which developed the LARIAT device for left atrial appendage closure in patients with atrial fibrillation. A press release reports that the transaction consideration consists of an upfront payment of approximately US$40 million in cash and AtriCure common stock, plus additional contingent [...]

2019-09-16T15:38:00+00:00September 16th, 2019|Tags: , , , |

Novel repositionable TAVI valve has acceptable early clinical outcomes

Source: BIBA MedTech TAVI Monitor A new study indicates that the Meridian transcatheter aortic valve implantation (TAVI) valve (HLT) is associated with a 30-day mortality rate of 8% and a six-month mortality rate of 12%. The valve is fully retrievable after deployment, which allows an accurate assessment of valve positioning and performance [...]

2019-09-06T18:24:17+00:00September 6th, 2019|Tags: |

Poll favours interventional radiologists to perform mechanical thrombectomy in lieu of neurointerventionalists

Source: BIBA MedTech Insights According to a BIBA MedTech survey, 52% of neurointerventionalists believe that they are the only specialists who have the relevant skills and experience to perform interventional stroke procedures (e.g. mechanical thrombectomy). However, of those who believe other specialities—with the appropriate training—could potentially perform such procedures, 58% propose interventional [...]

2019-08-21T09:57:07+00:00August 20th, 2019|Tags: , , |

CE mark reinstated for Nellix endovascular aneurysm sealing system

Source: BIBA MedTech Aortic Segmentation Monitor Endologix has announced that the CE mark for the Nellix endovascular aneurysm sealing (EVAS) system has been reinstated. The CE mark for the system was suspended on 22 January and now it that has been reinstated, Nellix will be made available for use at approved centres [...]

2019-08-27T14:37:44+00:00August 9th, 2019|Tags: , , , |

Edwards Lifesciences drops its self-expanding TAVI valve in favour of focusing on its balloon-expanding range

Source: BIBA MedTech TAVI Monitor Edwards Lifesciences—in a press statement announcing its global second quarter (Q2) financial results—has revealed that it is taking the self-expanding transcatheter aortic valve implantation (TAVI) device Centera off the market. The company says resources will instead be focused on the balloon-expanding Sapien range of TAVI devices, adding [...]

2019-08-09T11:01:06+00:00August 9th, 2019|Tags: , , , |

PCI Insights Q1 2019

In this edition, we review (in Market Insights) the key Q1 2019 findings of the BIBA MedTech PCI Monitor—which tracks, on a quarterly basis, the percutaneous coronary intervention (PCI) procedures performed and the coronary devices used in Western Europe. We also explore the latest news (see Technology Insights) and look at pipeline developments (go [...]

2019-08-21T10:14:41+00:00July 30th, 2019|Tags: , |