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 [...]
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 [...]
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 [...]
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 [...]
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 [...]
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” [...]
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 [...]
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 [...]
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 [...]
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 [...]
Miles D White will be stepping down, after 21 years, as CEO of Abbott on 31 March 2020. According to a press release, White’s tenure is the second longest for a non-founder in today’s S&P 100; he will remain executive chairman of the Board. The Board has unanimously appointed Robert B Ford—a 23-year Abbott [...]
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) [...]
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 [...]
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 [...]
Abbott has announced its TRILUMINATE Pivotal trial to evaluate the safety and effectiveness of the TriClip transcatheter tricuspid valve repair system for the treatment of severe tricuspid regurgitation. This is the first pivotal Investigational Device Exemption (IDE) trial in the USA to evaluate a catheter-based, non-surgical treatment for patients with severe tricuspid regurgitation. The [...]
MitraClip XTR Abbott has received US FDA approval for fourth-generation version of its MitraClip heart valve repair device (MitraClip G4) to treat mitral regurgitation. This latest version, according to a press release, delivers an expanded range of clip sizes, an alternative leaflet grasping feature and facilitation of procedure assessment in real time [...]