Clinical Trials: Page 12
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Edwards presents 6-month data on Pascal, eyeing MitraClip
The structural heart giant's CE-marked system showed sustained mitral regurgitation improvement in patients. The company is gearing up for a head-to-head trial against Abbott's device, which is the only FDA-approved option.
By Maria Rachal • May 23, 2019 -
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FDA wants new companies to help test its Pre-Cert Program
One pilot company's CEO told MedTech Dive FDA's search for new companies "is not a surprise to us" and "is a really good thing for the Pre-Cert program."
By David Lim • May 23, 2019 -
Medtronic results build case for renal denervation device
One study linked Symplicity to a reduced occurrence of subclinical atrial fibrillation in a subset of high-risk patients.
By Nick Paul Taylor • May 23, 2019 -
Biotronik stent bests Medtronic in study of small-vessel lesions
Evidence from a sub-group analysis of a three-year clinical trial supports the theory that stents with very thin struts are less likely to require repeat revascularization in patients.
By Nick Paul Taylor • May 22, 2019 -
J&J's Auris unveils early results on Monarch robot for lung procedures
The FDA-cleared robotic platform successfully localized lung nodules in 92% of patients, Auris Health reported at the American Thoracic Society Conference.
By Susan Kelly • May 21, 2019 -
Titan Medical's losses balloon as robotic surgery R&D drive accelerates
The company plans to file for a CE mark and 510(k) clearance for its robotic surgery platform by the end of the fiscal year. It aims to start early U.S. commercialization in 2020.
By Nick Paul Taylor • May 16, 2019 -
Medtronic posts data on stent grafts and venous closure systems
The endosuture aneurysm repair and chronic venous disease data suggest the efficacy seen earlier in the studies is durable.
By Nick Paul Taylor • April 18, 2019 -
Pfizer, Concerto collaborate on AI in precision oncology
The agreement is Concerto's second AI collaboration with a big pharma company in recent weeks and will focus on identifying new treatment options, refining study designs and speeding completion times for outcome studies.
By Susan Kelly • April 10, 2019 -
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TAVR called 'game changing' in studies of low-risk patients
Data from Edwards Lifesciences' Partner 3 trial and Medtronic's Evolut Low Risk study prompted predictions that TAVR will become the preferred option for a wider population of heart valve patients.
By Susan Kelly • March 18, 2019 -
Apple
Apple heart study: Early proof of concept, or a gimmick?
Doctors at the American College of Cardiology meeting said the Apple Watch's foray into health monitoring needs more data to prove its value.
By David Lim • March 16, 2019 -
Apple, Medtronic and more medtech to track at ACC19
Anticipated data backing the tech giant's heart rhythm-tracking watch, results from Medtronic and Edwards aimed at broader use of TAVR procedures, and an update on Abbott's MitraClip highlight the annual conference.
By Maria Rachal • March 14, 2019 -
TAVR for low-risk patients in spotlight at ACC
Jefferies analysts predict results from valve makers Edwards Lifesciences and Medtronic will "usher in the low risk era for TAVR," expanding the market for the devices.
By Susan Kelly • March 11, 2019 -
Tandem suspends software use in pivotal closed loop study to fix bug
The company sought to quell nerves, but investors pushed the stock down 8% on safety concerns.
By Nick Paul Taylor • March 7, 2019 -
Medtronic says corrected IN.PACT analysis to be published in JACC
The revision, prompted by a data error, complicates an already contentious debate about long-term safety of drug-coated balloons in treating peripheral artery disease.
By Susan Kelly • March 4, 2019 -
Guardant Health
Liquid biopsy as effective as tissue biopsy in lung cancer, study finds
A clinical trial found Guardant Health's test detected advanced non-small cell lung cancer at a similar rate to traditional tissue-based biopsies.
By Emily Mullin • March 1, 2019 -
Boston Scientific Lotus matches Medtronic CoreValve in head-to-head TAVR trial
The readout comes as Boston Scientific prepares to introduce its device in the U.S. and Europe.
By Nick Paul Taylor • Feb. 28, 2019 -
Dollar Photo Club
Myriad plans companion diagnostic filing as PARP drug clears clinical test
The company said Thursday its BRACAnalysis CDx diagnostic will be used to find germline BRCA mutations in men with certain prostate cancers in a Phase 3 study.
By Nick Paul Taylor • Updated April 4, 2019 -
Biotronik's drug-eluting stent expands to US market with PMA
The Orsiro system for coronary artery disease will play against Abbott's Xience and Medtronic's Resolute.
By Maria Rachal • Feb. 25, 2019 -
FDA rule on device study practices comes into force
The final rule mandates the use of good clinical practices by sponsors of trials based outside the U.S.
By Nick Paul Taylor • Feb. 22, 2019 -
FDA panel backs vaginal mesh option, wants more data
The agency will consider recommendations from the obstetrics and gynecology devices panel as it makes decisions on premarket approval applications from Boston Scientific and Coloplast.
By Maria Rachal • Updated Feb. 14, 2019 -
Deep Dive
CMS eases study parameters in depression device coverage decision
LivaNova seeks to enroll clinical trial patients beginning in the third quarter of 2019. Those patients will only need to demonstrate response rather than remission, per CMS updates to the finalized decision memo.
By Maria Rachal • Updated Feb. 19, 2019 -
FDA sets neurology, microbiology device panel meetings for March
Advisory committees will discuss a De Novo application for an Alzheimer's therapy and new approaches to evaluate HPV screening devices.
By Maria Rachal • Jan. 31, 2019 -
LivaNova highlights studies into efficacy, value of sutureless aortic valve
The research suggests the valve, Perceval, may have advantages over competing technologies.
By Nick Paul Taylor • Jan. 18, 2019 -
Brian Tucker / MedTech Dive
Regulatory makeovers and international game changers: MedTech Dive's top stories of 2018
Hard looks at cybersecurity and digital health's hot streak also left their mark on the year.
By Maria Rachal • Dec. 22, 2018 -
Bayer, FDA lengthen Essure postmarketing study to 5 years
The German pharma announced in July it would no longer sell the birth control implant in the U.S. due to falling sales.
By David Lim • Dec. 21, 2018
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