Clinical Trials: Page 11
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Medtronic touts new data on DCB in dialysis patients
The IN.PACT drug coated balloon received an expanded CE mark indication in January 2016 to treat AV access for patients with end-stage renal disease.
By David Lim • Sept. 9, 2019 -
Racing Edwards, Abbott starts pivotal trial of tricuspid device
The product, a sibling of MitraClip, could become the first transcatheter tricuspid device of its kind on the U.S. market.
By Nick Paul Taylor • Sept. 6, 2019 -
Biotronik's Orsiro stent beats Abbott's Xience in head-to-head trial
The trial linked the "ultrathin" Orsiro to a lower rate of target lesion revascularization than Abbott's incumbent device.
By Nick Paul Taylor • Sept. 4, 2019 -
FDA urges providers, manufacturers to transition to duodenoscopes with disposable parts
Boston Scientific told investors last year single-use duodenoscopes represent a market opportunity of more than $1 billion dollars.
By David Lim • Aug. 30, 2019 -
Surmodics passes milestone in trial of Abbott-licensed paclitaxel-coated balloon
Surmodics completed enrollment sooner than some analysts expected on a trial comparing its paclitaxel-coated balloon to Medtronic's IN.PACT Admiral.
By Nick Paul Taylor • Aug. 29, 2019 -
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Titan Medical delays 510(k) submission until 2020 amid cash burn concerns
The company plans to use the delay to spread out its spending while working to implement the robotic surgery system's sterile instrument interface components, software improvements and training tools.
By David Lim • Aug. 27, 2019 -
Brian Tucker
Big data, cybersecurity among top FDA device center priorities
Reprocessing of devices and biocompatibility are also addressed in a report intended to incorporate new tech into regulatory decisions.
By David Lim • Aug. 23, 2019 -
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ViewRay touts promising early results from localized prostate cancer trial after disappointing quarter
Weeks after cutting revenue targets for 2019, the company reported low incidence of early gastrointestinal and genitourinary toxicity in patients who received the magnetic resonance-guided radiation therapy.
By Maria Rachal • Aug. 21, 2019 -
FDA approves MRI labeling for Boston Scientific DBS system
CEO Michael Mahoney touted the growth of the company's deep brain stimulation products to investors during its second quarter earnings call.
By David Lim • Aug. 20, 2019 -
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Edwards, Medtronic win expanded indications for low-risk TAVR patients
Roughly 165,000 low-risk patients per year in the U.S., Western Europe and Japan could now be eligible for the procedure, Medtronic estimates, a population both medtechs will be keen to treat.
By David Lim , Maria Rachal • Updated Aug. 16, 2019 -
Mercy Technology Services
Mercy expands RWE program to capture data from other providers
The expansion of the network follows real-world evidence deals with BD, Johnson & Johnson and Medtronic.
By Nick Paul Taylor • Aug. 16, 2019 -
Hearing industry calls Bose self-fit hearing aid study flawed in complaint to FDA
The Hearing Industries Association letter argues the device's Phase II clinical study "does not provide enough evidence of effectiveness of the self-fitting method given the study's initial reliance on professionals for fitting."
By David Lim • Aug. 15, 2019 -
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Imaging study links poorly controlled blood pressure to marker of cognitive decline
A NIH-funded imaging trial found intensive blood pressure treatment tied to reductions in lesions associated with cognitive decline.
By Nick Paul Taylor • Aug. 14, 2019 -
FDA to update paclitaxel device labels with mortality signal warning
The agency and manufacturers such as BD, Medtronic and Boston Scientific are planning research into the devices' long-term safety profile using new randomized trials and registry datasets.
By David Lim • Updated Aug. 8, 2019 -
Titan Medical warns robotic surgery filing target may slip
The Canadian medtech called the regulatory filing schedule "very tight" and "not completely within [its] control."
By Nick Paul Taylor • July 24, 2019 -
CVS launches home hemodialysis device clinical trial
The drugstore giant, which now includes insurance heavyweight Aetna, argues it can help reduce the $35 billion in Medicare costs associated with the treatment of end-stage renal disease.
By David Lim • July 17, 2019 -
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FDA finalizes IDE broadcasting guidance, with concessions to industry
The final text is a major rewrite of a 2014 draft, which was criticized by AdvaMed.
By Nick Paul Taylor • July 11, 2019 -
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Medtronic HVAD shows low stroke risk in study of thoracotomy approach
The clinical data could help Medtronic reverse market share losses to Abbott, which makes a competing left ventricular assist device for patients suffering from advanced heart failure.
By Susan Kelly • July 9, 2019 -
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FDA offers guidance on data for prostate ablation devices
The document addresses clinical studies for general surgical tools for prostate tissue ablation, differentiating them from technologies treating specific diseases like prostate cancer or benign prostatic hyperplasia.
By Susan Kelly • June 26, 2019 -
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Label should warn patients of paclitaxel device mortality signal, FDA panel says
The advisory committee struggled through the two-day meeting evaluating the safety of the devices due to incomplete data. Members agreed more data is needed but differed on the method the agency should use to collect it.
By David Lim • June 21, 2019 -
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As CMS decision on TAVR looms, a push for broader access
Proposed agency rules would lower the bar for hospitals performing the less invasive heart procedure, but would also raise the eligibility requirements to offer the treatment.
By Nick Paul Taylor • June 18, 2019 -
Beta Bionics, Insulet seek shake-up of insulin delivery market at ADA
Data presented at the American Diabetes Association meeting move the companies a step closer to challenging Medtronic and Tandem.
By Nick Paul Taylor • June 11, 2019 -
Device interoperability, CGM for Type 2 patients among ADA 2019 standouts
More options for automated insulin dosing systems are emerging, particularly as FDA established new device classifications for interoperable pumps and glycemic controller algorithms via the De Novo pathway.
By Maria Rachal • June 10, 2019 -
Abbott and Tandem in the spotlight at diabetes meeting
Abbott is sharing details of its FreeStyle Libre 2 CGM system, and Tandem is presenting data on its automated insulin delivery system.
By Nick Paul Taylor • June 7, 2019 -
Philips' 3-year data links drug-coated balloon to sustained benefits
The company's low-dose paclitaxel-coated Stellarex beat or matched uncoated balloons on key endpoints, including rates of primary patency and mortality.
By Nick Paul Taylor • May 30, 2019
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