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: , , |

Virtual ACC: More positive data for Medtronic’s renal denervation system

Symplicity Spyral Data published in the Lancet—and simultaneously presented at the American College of Cardiology together with World Congress of Cardiology Scientific Sessions (ACC.20/WCC) virtual meeting (28–30 March, Central Time)—provide further evidence that renal denervation with the Symplicity Spyral (Medtronic) catheter is an effective approach for lowering blood pressure in patients who [...]

2020-04-07T12:38:17+00:00April 7th, 2020|Tags: , , , , |

COVID-19: Medtronic shares ventilation design specs to speed up global production

Medtronic is publicly sharing the design specifications for the Puritan Bennett 560 (PB 560) to enable participants across industries to evaluate options for rapid ventilator manufacturing to help efforts to manage patients with COVID-19. A press release reports that this this decision is consistent with the recent FDA Guidance and in accordance with the [...]

2020-04-02T16:32:54+00:00April 2nd, 2020|Tags: , |

Virtual ACC: Positive data for Medtronic’s Evolut TAVI system in low-risk patients with bicuspid aortic valve stenosis

Late-breaking data presented at the American College of Cardiology together with World Congress of Cardiology Scientific Sessions (ACC.20/WCC) virtual meeting (28–30 March, Central Time) show that transcatheter aortic valve implantation (TAVI) with the Evolut device (Medtronic) in low-risk patients with bicuspid aortic valves is associated with low rates of all-cause mortality or stroke at [...]

2020-04-02T11:56:58+00:00April 2nd, 2020|Tags: , , , |

Medtronic acquires UK company Digital Surgery

Medtronic has announced its acquisition of Digital Surgery, which is a privately-held pioneer in surgical artificial intelligence (AI), data and analytics, and digital education and training. A press release says that the acquisition will strengthen the Medtronic robotic-assisted surgery platform and has applicability for the Medtronic broader portfolio. The terms of the agreement have [...]

2020-02-17T13:49:00+00:00February 17th, 2020|Tags: , , , |

Medtronic starts new pilot study of its Symplicity Spyral renal hypertension system

Medtronic has said it will begin enrolment in a pilot study evaluating the safety and efficacy of the Symplicity Spyral renal denervation system using a targeted procedural approach with a reduced number of radio frequency ablations. Set to enrol 50 patients at up to 15 sites in the USA and Europe, the single-arm study [...]

2020-02-10T13:56:26+00:00February 10th, 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: , , , |

AF Symposium 2020: Myocardial specificity of pulsed field ablation provides safety advantage for persistent AF

Vivek Reddy At the AF Symposium 2020 (23–25 January, Washington, DC, USA), Vivek Y Reddy (Helmsley Electrophysiology Center, Icahn School of Medicine at Mount Sinai, New York, USA) reported that pulsed field ablation (PFA)—with the Farawave (Farapulse Inc.) catheter—may be a feasible and safe approach for treating patients with persistent atrial fibrillation [...]

2020-01-31T09:37:07+00:00January 30th, 2020|Tags: , , , |

FDA approve Micra AV for the management of atrioventricular block

Medtronic has received FDA approval of Micra AV, which a press release describes as “the world’s smallest pacemaker with atrioventricular (AV) synchrony”; the pacemaker is indicated for the treatment of patients with AV block. The press release states that Medtronic “now offers the first and only FDA-approved leadless pacemaker portfolio, expanding the number of [...]

2020-01-28T18:20:37+00:00January 28th, 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 [...]

Medtronic acquires pioneer of a novel spinal cord stimulation waveform

Intellis Medtronic has acquired Stimgenics, which a press release reports has pioneered a novel spinal cord stimulation (SCS) waveform known as “differential target multiplexed” (DTM) spinal cord stimulation. The press release adds that the therapy, which is delivered via the Medtronic Intellis platform, is a new and unique programming option to treat [...]

2020-01-15T15:26:39+00:00January 15th, 2020|Tags: , , , |

Medtronic receives FDA clearance for Stealth Autoguide system for cranial procedures

The FDA has cleared the Stealth Autoguide system (Medtronic), which a press release reports is the first cranial robotic platform to integrate with Medtronic’s enabling technology portfolio to create an end-to-end procedural solution. The Stealth Autoguide Platform is a robotic guidance system intended for the spatial positioning and orientation of instrument holders or tool [...]

2020-01-03T11:51:16+00:00January 3rd, 2020|Tags: , , |

FDA approval of IN.PACT AV is a boon for management of dysfunctional AVFs

Andrew Holden Recently, the FDA approved Medtronic’s paclitaxel-coated balloon IN.PACT AV for the management of failing arteriovenous fistulae (AVF). Approval for the device was based on data from the IN.PACT AV Access trial, which showed the device to significantly increase primary patency compared with standard percutaneous transluminal angioplasty. Andrew Holden (Department of [...]

FDA greenlight Medtronic’s paclitaxel-coated balloon for treating arteriovenous fistula lesions

IN.PACT AV Medtronic has announced FDA approval of its IN.PACT AV drug-coated balloon—a paclitaxel-coated balloon indicated for the treatment of failing arteriovenous access in patients with end-stage renal disease (ESRD) undergoing dialysis. According to a press release, randomised trial results from the IN.PACT AV Access trial show that IN.PACT AV drug-coated balloon [...]

2019-11-25T13:06:38+00:00November 25th, 2019|Tags: