Approvals & refusals—February 2020

In February, Abbott received FDA Breakthrough Device Designation for a fully implantable left ventricular assist device, Biotronik received the CE mark for its Osiro Mission drug-eluting stent, and BlueGrass Vascular Technologies got a FDA de novo classification order for its Surfacer Inside-Out access catheter system. CE marks CE mark—Fist compression device (Fist Assist Devices) [...]

2020-03-05T12:19:16+00:00March 5th, 2020|Tags: |

HydroPICC central catheter from Access Vascular receives FDA clearance

Hero Access Vascular has announced that it has received clearance from the FDA for the second generation of its HydroPICC peripherally inserted central catheter (PICC), which has demonstrated a thrombus accumulation rate 30 times less than traditional PICCs and the potential to significantly reduce catheter occlusions. PICCs have become an increasingly popular [...]

2020-03-05T11:19:12+00:00March 5th, 2020|Tags: , , , |

Fist Assist Devices announces CE mark for its compression device

Fist Assist Devices has received the CE mark and has begun marketing the Fist Assist device for vein enhancement and enlargement in the European Union and other countries that recognise the CE mark. According to the press release, Fist Assist is the only wearable, patent-protected, intermittent compression device to increase vein diameter prior to [...]

2020-02-27T13:26:21+00:00February 27th, 2020|Tags: , , |

FDA Breakthrough Device Designation for Cardiovalve tricuspid valve replacement system

Cardiovalve has received FDA approval for an early feasibility study of its transcatheter tricuspid valve replacement system for a tricuspid regurgitation indication; the Cardiovalve system also has been granted Breakthrough Device Designation status by the FDA. Cardiovalve commenced its study for tricuspid regurgitation in the USA earlier this year. The study’s primary endpoint is [...]

2020-02-27T13:07:05+00:00February 27th, 2020|Tags: , |

FDA clearance for SuperMap high-resolution mapping algorithm

SuperMap (Acutus Medical) Acutus Medical has announced FDA clearance of SuperMap, which a press release calls a revolutionary addition to the company’s AcQMap 3D imaging and mapping system. It adds that SuperMap is a high-fidelity, high-resolution mapping algorithm for both stable and transient arrhythmias. Furthermore, SuperMap’s user interface effortlessly guides electrophysiologists to [...]

2020-02-27T16:55:42+00:00February 27th, 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: , |

FDA grants de novo clearance to Bluegrass Vascular Technologies for the Surfacer Inside-Out access catheter system

Bluegrass Vascular Technologies (BVT) has announced that the FDA has granted a de novo classification order for its Surfacer Inside-Out access catheter system. A press release reports that the Surfacer system is intended to obtain central venous access to facilitate catheter insertion into the central venous system for patients with upper body venous occlusions [...]

Orsiro Mission receives CE mark

Orsiro Mission Biotronik now has the CE mark for its Orsiro Mission drug-eluting stent system. According to a press release, the next-generation of the company’s ultrathin strut Orsiro drug-eluting stent provides higher deliverability than other contemporary stents. The press release states that the Orsiro Mission “has a completely re-engineered delivery system to [...]

2020-02-17T12:59:36+00:00February 17th, 2020|Tags: , , |

FDA grants Caption Health authorisation for first AI-guided image acquisition system

Caption guidance Caption Health has announced that the FDA has authorised marketing of Caption Guidance software, which is designed to assist medical professionals in the acquisition of cardiac ultrasound images. The system uses artificial intelligence (AI) to provide real-time guidance and diagnostic quality assessment of images. The aim is to empower healthcare [...]

2020-02-10T17:58:02+00:00February 10th, 2020|Tags: , , , |

XableCath crossing catheters have received CE mark for peripheral use

XableCath has announced that its XableCath Crossing catheters have received CE mark for peripheral use. Its crossing devices will be available for sale in Europe in two versions, a blunt tip and an abrasion tip, in a variety of diameters and lengths. XableCath received US Food and Drug Administration (FDA) clearance for its crossing [...]

2020-02-10T14:44:43+00:00February 10th, 2020|Tags: , |

FDA Breakthrough Designation for device for treating pulmonary arterial hypertension

The FDA has granted Breakthrough Device Designation for the Aria CV pulmonary hypertension system (Aria CV PH System). A press release reports that Aria has already performed a successful acute first- in-human clinical study in Vienna, Austria, and is now preparing for a US clinical trial under the FDA’s early feasibility study programme to [...]

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: , , , |

Selution SLR receives CE mark for endovascular applications

MedAlliance has announced that it now has the CE mark for the Selution SLR—a sirolimus drug-eluting balloon for the treatment of peripheral arterial disease. This approval applies to sizes from 2x20mm to 7x150mm. According to a press release, this award was supported by two-year results from the SELUTION SLR first-in-human study, which involved 50 [...]

2020-02-05T12:54:47+00:00February 5th, 2020|Tags: , , |

CE mark for Cobalt for Crome portfolio of ICDs and CRT-Ds

Cobalt ICD Medtronic has received the CE mark for its Cobalt and Crome portfolio of implantable cardioverter-defibrillators (ICD) and cardiac resynchronisation therapy-defibrillators (CRT-D). With the launch of the Cobalt and Crome platform, Medtronic also is making TriageHF technology available. A press release reports that this technology assesses patients’ heart failure risk through [...]

2020-02-05T12:40:29+00:00February 5th, 2020|Tags: , , , |