Evolut now has CE mark for low-risk patients and has new labelling for bicuspid use

Evolut Medtronic has been awarded CE mark for the use of the Evolut transcatheter aortic valve implantation (TAVI) system for patients with severe native aortic stenosis who are at low surgical risk. The Evolut TAVI platform has also received a new indication approval for the treatment of patients with bicuspid aortic valves [...]

2020-06-23T11:39:41+00:00June 23rd, 2020|Tags: , , |

Medtronic receives US FDA approval for Cobalt and Crome implantable ICDs

Cobalt ICD Medtronic has received FDA approval for its Cobalt and Crome implantable cardioverter-defibrillators (ICD) and cardiac resynchronisation therapy-defibrillators (CRT-D). ICDs monitor heart rhythms and deliver therapy to correct heart rates that are too fast and can lead to sudden cardiac arrest. CRT-Ds, a treatment option for some individuals with heart failure, [...]

2020-05-11T15:54:02+00:00May 11th, 2020|Tags: , , |

Terumo Aortic announces FDA approval for Treo endovascular device

Treo stent graft Terumo Aortic has announced that the FDA has granted approval of the Treo abdominal aortic stent-graft system for sale in the USA for the treatment of patients with abdominal aortic aneurysms (AAA). According to a press release, Treo is the only device commercially available for endovascular aneurysm repair (EVAR) with dual [...]

2020-05-11T15:56:25+00:00May 11th, 2020|Tags: , , |

FDA clears Aspire MAX mechanical thrombectomy system

Aspire MAX mechanical thrombectomy system Control Medical Technology has announced that the US Food and Drug Administration (FDA) has cleared its Aspire MAX 7 – 11F mechanical thrombectomy platform to remove blood clots from peripheral vessels. “This FDA clearance quadruples our product offering and improves our ability to help patients,” said Shawn Fojtik, president [...]

2020-05-11T15:40:56+00:00May 11th, 2020|Tags: , |

LifeSignals receives CE mark for the ECG Remote Monitoring Patch

LifeSignal remote monitoring patch LifeSignals has received CE mark approval for the LifeSignals ECG Remote Monitoring Patch, a disposable wireless remote monitoring system, intended for use by healthcare professionals for continuous collection of Electrocardiography (ECG) and heart rate monitoring in ambulatory, hospital, healthcare and home settings. Patient data can be transmitted wirelessly [...]

2020-05-11T15:27:53+00:00May 11th, 2020|Tags: , |

CE mark for SuperSaturated oxygen therapy

TherOX DS2 ZOLL Medical has received CE Mark approval to market and distribute its SuperSaturated oxygen (SSO2) therapy system in Europe. A press release reports that SSO2 therapy provides interventional cardiologists with the first and only clinically proven treatment beyond percutaneous coronary intervention (PCI) to significantly reduce muscle damage in myocardial infarction [...]

2020-05-11T15:20:51+00:00May 11th, 2020|Tags: , , , |

Terumo Aortic announces US FDA breakthrough device designation for Thoraflex Hybrid device

Thoraflex Hybrid stented device Terumo Aortic today announced that the US Food and Drug Administration (FDA) has granted breakthrough device designation for its Thoraflex Hybrid stented device for complex aortic arch repair. The purpose of the FDA’s breakthrough device designation programme is to fast-track the regulatory review process for certain medical technologies and device-led [...]

2020-05-01T11:09:46+00:00May 1st, 2020|Tags: , , |

Cerus Endovascular’s 021 Contour neurovascular system approved in Europe

Cerus Endovascular has received CE mark approval for its 0.021-inch Contour neurovascular system, compatible with smaller commercially available 021 microcatheters for the treatment of saccular intracranial aneurysms. According to the company, the Contour neurovascular system is a fine mesh braid that is deployed across the neck of the aneurysm sac and provides a combination [...]

CE mark granted to the first biodegradable drug-eluting microspheres, BioPearl

Terumo Europe today announced that their BioPearl microspheres have received CE mark, providing a new option for patients eligible for locoregional embolization for the treatment of liver cancer. BioPearl microspheres are designed to preserve post-transarterial chemoembolization (TACE) target artery access, opening up the potential for cyclic treatment. Currently, drug-eluting microsphere TACE (DEM-TACE) and conventional TACE are both [...]

2020-05-06T07:56:49+00:00May 1st, 2020|Tags: , , |

FDA Breakthrough Device Designation for novel heart failure therapy

VisCardia, Inc. VisCardia has been granted Breakthrough Device Designation from the US Food and Drug Administration (FDA) for its implantable VisONE system, which is designed for the treatment of moderate-to-severe heart failure with reduced ejection fraction and preserved ventricular synchrony. A press release reports that VisONE has now completed the first phase of the [...]

2020-05-01T10:31:34+00:00May 1st, 2020|Tags: , , , |

Tack Endovascular System receives FDA approval for below-the-knee post-angioplasty dissection repair

Tack Endovascular System (4F) Intact Vascular has received FDA approval for the Tack Endovascular System (4F), a novel, minimal metal implant for precision dissection repair in the mid/distal popliteal, tibial and/or peroneal arteries. Regulatory approval was based on data from Intact Vascular’s Tack Optimised Balloon Angioplasty II BTK (TOBA II BTK) clinical [...]

2020-04-16T15:20:44+00:00April 16th, 2020|Tags: , , |

Axonics wins FDA approval for its next-generation implantable neurostimulator

Axonics has announced the FDA approval of its next-generation rechargeable implantable neurostimulator for its r-SNM system under a premarket approval (PMA) supplement. This next-generation implantable neurostimulator decreases how frequently a patient needs to recharge their implanted device to once a month for about one hour. This compares to the current recharging interval which is [...]

2020-04-16T14:43:49+00:00April 16th, 2020|Tags: , |

COVID-19: FDA authorise blood purification device for treating virus

The US Food and Drug Administration (FDA) issued an emergency use authorisation for a blood purification system (Spectra Optia Apheresis System, Terumo BCT) combined with Adsorption Cartridge (Marker Therapeutics) to treat patients 18 years of age or older with confirmed COVID-19 admitted to the intensive care unit (ICU) with confirmed or imminent respiratory failure. A [...]

2020-04-16T13:35:58+00:00April 16th, 2020|Tags: , , |