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Clinical Trials

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Results Recap: CRT In DC Features New Biotronik Stent Data, Encouraging TAVR Low-Risk Data; Ablative Systems’ Alcohol Renal Denervation

Medtech Insight's Results Recap covers major device trial results appearing on MedDeviceTracker. This week's edition, covering March 1 to March 7, includes results of late-breaking trials presented at the 2019 Cardiovascular Research Technologies (CRT) conference in Washington, DC, including new data supporting Biotronik’s biodegradable polymer sirolimus-eluting stent and the company’s resorbable magnesium stent, results of the LRT trial of transcatheter aortic valves in low-risk patients, plus promising clinical data supporting Ablative System’s alcohol renal-denervation system.

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Results Recap: EndoBarrier Improves Obesity And Diabetes Outcomes In UK Study; Procept’s Aquablation Proves Effective Again

Medtech Insight's Results Recap covers major device trial results appearing on MedDeviceTracker. This week's edition covers new clinical data released March 8 to March 22, not including the data presented at the annual conferences of the American Academy of Orthopedic Surgeons or American College of Cardiology, which are presented in separate special editions of Results Recap.

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Device Week, March 22, 2019 – Goings-On At US FDA

In this week’s podcast, senior reporters Elizabeth Orr and Ferdous Al-Faruque give a quick rundown of FDA goings-on the device industry should keep a sharp eye on, including a reorganization of the Center for Devices and Radiological Health, remarks from outgoing agency head Scott Gottlieb on laboratory developed tests, and news from a recent FDA neurological devices advisory panel meeting.

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Neuro Devices Panel Skeptical On Alzheimer’s Treatment

The US FDA neurological devices panel on March 21 found significant faults with Neuronix’s de novo application for its neuroAD Alzheimer’s treatment system. A key concern was that the device missed its primary endpoint in the pivotal trial.

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ACC Results Recap Part III: RADIANCE-HTM SOLO Results Support ReCor’s Renal Denervation System

Medtech Insight's Results Recap is a regular feature covering the major device trial results compiled by MedDeviceTracker. This is the third of three Results Recaps covering trial data presented at the American College of Cardiology Scientific Sessions in New Orleans, March 16-18, including the final results of the MOMENTUM 3 trial of Abbott’s HeartMate 3 left-ventricular assist device and six-month results from the RADIANCE-HTN SOLO trial of ReCor’s Paradise renal denervation system, and more. Check out Part I and Part II of our ACC Results Recap.

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QUOTED. March 22, 2019. Scott Gottlieb.

US FDA recently qualified the OsiriX CDE Software Module as a Medical Device Development Tool (MDDT), making it the third MDDT qualified by the agency and the first biomarker MDDT. See what FDA Commissioner Scott Gottlieb said about it here.

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QUOTED. March 21, 2019. Martin Leon.

In this week's Results Recap, covering trial data from the American College of Cardiology Scientific Sessions in New Orleans, March 16-18, Martin Leon from Columbia University presented results from the PARTNER 3 trial, comparing Edwards Lifesciences Corp.'s balloon-expandable Sapien 3 transcatheter aortic valve system to open valve surgery. See what Martin Leon from Columbia University said about it here.

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ACC Results Recap Part II: CardioMEMS Post-Approval Trial Shows Monitoring Reduces Heart-Failure Hospitalizations; Medtronic’s Tyrx Envelope Reduces Infections

Medtech Insight's Results Recap is a regular feature covering the major device trial results compiled by MedDeviceTracker. This is the second of three Results Recaps covering trial data presented at the American College of Cardiology Scientific Sessions in New Orleans, March 16-18, including clinical trial data on devices from Abbott Laboratories, Medtronic, Medi-Lynx, and iRhythm. See Part 1 of our ACC Results Recap for more on the groundbreaking trials of transcatheter aortic valve replacement in low-risk patients and the Apple Heart study of Apple Watch's ability to track atrial fibrillation.

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No Brainer: US FDA Greenlights First Biomarker Software As Medical Device Development Tool For Brain Injury

Developers of medical devices intended to treat traumatic brain injuries may want to consider using an imaging software developed to detect contusions. The product is the third Medical Device Development Tool qualified by US FDA, which means the agency trusts it to output accurate data supporting clinical trials.

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QUOTED. March 20, 2019. William Mihalko.

In this week's Results Recap covering trial data from the American Academy of Orthopedic Surgeons Annual Meeting in Las Vegas March 12-16, Myoscience released encouraging preliminary results from a 125-patient study on its Iovera cryoanalgesia therapy. See what the presenter of the results, William Mihalko, from Campbell Clinic of Germantown, Tennessee, said about it here.

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