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Clinical / R & D
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FDA Approves CVRx’s Barostim Neo For Heart Failure On Expedited Pathway
The PMA approval is based on the results of the BeAT HF trial, which showed that baroflex activation therapy with Barostim Neo safely improves quality-of-life scores and exercise capacity in patients with heart failure and reduced ejection fraction.
Clinical Trials
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Latest From Clinical Trials
Stanford Launches Trial Of NeuroPace’s Responsive Neuromodulation To Stop Overeating
The DBSLOC trial will study the feasibility of using NeuroPace’s RNS responsive neuromodulation system to stimulate the nucleus accumbens in order to stop “loss-of-control” eating in people with treatment-refractory obesity, especially those who have failed to respond adequately to gastric bypass surgery.
EU To Join Countries Covered By India’s Clinical Investigation Waiver Rule
Indian regulators intend to waive their clinical investigation requirements for certain medical devices that are already approved in the EU.
FDA Expands TAVR Indication To Low-Risk Patients
As expected, the US FDA has expanded the approved indication for four transcatheter aortic valves – Edwards Lifescience’s Sapien 3 and Sapien 3 Ultra, and Medtronic’s CoreValve Evolut R and CoreValve Evolut PRO – to include patients at low risk for complications during surgery.
New Technology
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Latest From Innovation
Stanford Launches Trial Of NeuroPace’s Responsive Neuromodulation To Stop Overeating
The DBSLOC trial will study the feasibility of using NeuroPace’s RNS responsive neuromodulation system to stimulate the nucleus accumbens in order to stop “loss-of-control” eating in people with treatment-refractory obesity, especially those who have failed to respond adequately to gastric bypass surgery.
QUOTED. 22 August 2019. Omar Ishrak.
While Medtronic PLC's Brain Therapies business was by far the fastest-growing unit in the first quarter of fiscal 2020, sales of spine surgery products grew faster in the first quarter than they have in nine quarters. See what Medtronic's CEO Omar Ishrak said about it here.
Brain Therapies Leads Medtronic’s Growth In First Quarter Of Fiscal 2020
The medtech giant reported revenue of $7.5bn in the quarter that ended on 26 July, up 3.5% year-over-year basis, led by 12.5% growth in revenues from emerging markets. Medtronic’s fastest-growing business is its brain therapies unit, which reported 11.4% growth in the quarter.
Approvals
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Latest From Approvals
Hong Kong Poised To Speed Up Device Approvals
The Medical Device Control Office is to launch a trial program for expediting the approval of certain classes of medical devices.
Pediatric Scoliosis Device Nabs HDE Approval
The US FDA has approved Zimmer Biomet’s Tether device, which is the first device of its type cleared to treat children with a form of spinal curvature. It's also the first pediatric spinal device to net Humanitarian Device Exemption approval from the agency in 15 years, the company says.
FDA Expands TAVR Indication To Low-Risk Patients
As expected, the US FDA has expanded the approved indication for four transcatheter aortic valves – Edwards Lifescience’s Sapien 3 and Sapien 3 Ultra, and Medtronic’s CoreValve Evolut R and CoreValve Evolut PRO – to include patients at low risk for complications during surgery.
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