CE mark for transcatheter system that uses same clip technology as MitraClip

TriClip Abbott has received the CE mark for its TriClip transcatheter tricuspid valve repair system and is now approved for use in Europe and other countries that recognise the CE mark. It can, therefore, be used as a non-surgical treatment for people with a leaky tricuspid valve. A press release reports that [...]

2020-04-09T14:20:07+00:00April 9th, 2020|Tags: , , |

COVID-19 FDA grant Abbott emergency use authorisation to launch test for novel coronavirus

COVID-19 Abbott has announced that the FDA has issued Emergency Use Authorisation (EUA) for the its molecular test for COVID-19. According to a press release, Abbott is immediately shipping 150,000 Abbott RealTime SARS-CoV-2 EUA tests to existing customers in the USA. The tests are used on the company’s m2000 RealTime System. The [...]

2020-04-02T16:43:54+00:00April 2nd, 2020|Tags: , , |

Approval of Tendyne TMVI device means physicians now have a portfolio of options for treating mitral regurgitation

In January this year, Abbott made history when it became the first company in the world to receive market approval for a transcatheter mitral valve implantation (TMVI) device. Its Tendyne system now has a CE-mark indication for the management of patients with mitral regurgitation who cannot undergo mitral valve surgery or percutaneous edge-to-edge repair [...]

2020-03-05T10:17:44+00:00March 5th, 2020|Tags: , , |

CE mark for Abbott’s Gallant CRT-D and ICD

Gallant Abbott has received the CE mark for the new Gallant implantable cardioverter defibrillator (ICD) and cardiac resynchronisation therapy defibrillator (CRT-D) devices, which—a press release reports—have the most advanced heart rhythm management capabilities along with a new set of benefits to people in Europe with abnormal heart rhythms and heart failure. The [...]

2020-02-27T12:45:36+00:00February 27th, 2020|Tags: , |

“Our goal is to treat more patients with mitral regurgitation”

Patrick M McCarthy Last month, Abbott announced that that the FDA has approved a new trial—REPAIR MR—to evaluate the safety and efficacy of percutaneous edge-to-edge repair (MitraClip) for the management of patients with primary mitral regurgitation at moderate surgical risk. Currently, in both Europe and the USA, MitraClip has market approval for [...]

2020-02-10T13:21:31+00:00February 10th, 2020|Tags: , , |

FDA Breakthrough Device Designation for fully implantable left ventricular assist system

Robert Kormos The US Food and Drug Administration (FDA) has granted Breakthrough Device Designation to Abbott for its in-development fully implantable left ventricular assist system (FILVAS). The FDA Breakthrough Device Designation programme will allow, according to Robert L Kormos (medical director for mechanical circulatory support at Abbott), the company to “fast track” [...]

2020-02-05T14:10:54+00:00February 5th, 2020|Tags: , , , |

Abbott becomes first company in world to have transcatheter mitral implantation device on the market

The Tendyne transcatheter mitral valve implantation (TMVI) system (Abbott) has received the CE mark, making Abbott the first company to have such a device on a market anywhere in the world. A press release reports that this “life-changing” therapy treats significant mitral regurgitation in patients requiring a heart valve replacement and provides a safe [...]

2020-01-31T10:46:16+00:00January 30th, 2020|Tags: , , |

TAVI market changes in Q3 2019

Source: BIBA MedTech Insights TAVI Tracker The TAVI market in Western Europe grew by 19.2% between Q3 2018 and Q3 2019. Over the last three years, Edwards Lifesciences (the market leader) lost market share while Medtronic and Boston Scientific both gained market share. Boston Scientific’s acquisition of Symetis in Q2 2017 helped [...]

FDA approve less invasive technique with HeartMate 3 LVAD

The FDA has approved a new alternative surgical technique for the HeartMate 3 heart pump (Abbott) that will allow more advanced heart failure patients to avoid open heart surgery. The new, less invasive approach is designed to provide surgeons a choice in surgical method for patients receiving the HeartMate 3 left ventricular assist device [...]

2020-01-15T15:22:23+00:00January 15th, 2020|Tags: , , |

New trial will evaluate safety and efficacy of MitraClip for mitral regurgitation in moderate-risk patients

MitraClip XTR The FDA has approved a first-of-its-kind clinical trial that will compare the effectiveness of Abbott’s minimally invasive MitraClip device with open heart mitral valve surgical repair in people with primary mitral regurgitation who are eligible for open-heart surgery. If successful, a press release states, the trial has the potential to [...]

2020-01-15T14:51:51+00:00January 15th, 2020|Tags: , , |

TCT 2019: TRILUMINATE feasibility study meets both the primary safety and performance endpoints

TriClip New data indicate that a novel transcatheter system for tricuspid valve repair (TriClip, Abbott) was safe and associated with strong clinical improvement at six-months—including a reduction in tricuspid regurgitation and improvement in quality of life—in patients with severe tricuspid regurgitation. The findings were presented at the 2019 Transcatheter Cardiovascular Therapeutics (TCT) [...]

2019-10-01T13:20:16+00:00October 1st, 2019|Tags: , , |

FDA approves low-dose spinal cord stimulator for chronic pain

Proclaim XTR Abbott has received FDA approval for its Proclaim XR recharge-free neurostimulation system for people with chronic pain. A press release reports that the Proclaim XR platform offers a low dose of Abbott’s proprietary BurstDR stimulation waveform, which has been designed to mimic natural patterns found in the brain. The press [...]

2019-10-07T14:55:46+00:00October 1st, 2019|Tags: , , |

CE marks for Masters HP 15mm and Amplatzer Piccolo Occluder

Piccolo Occluder Two of Abbott’s paediatric devices—Masters HP 15mm rotatable mechanical heart valve and the Amplatzer Piccolo Occluder—have received European approval (CE mark). A press release reports that the devices, available in the USA, offer young paediatric patients and their families “hope when no other suitable treatment option may exist”.  The press [...]

2019-09-20T11:52:42+00:00September 20th, 2019|Tags: , , , |