Clinical Trials: Page 10
-
LivaNova loops Verily into depression device study
A clinical trial meant to support CMS coverage of the U.K. medtech's vagus nerve stimulation system will incorporate a wearable device and phone app from Alphabet's life sciences research organization.
By Maria Rachal • Feb. 27, 2020 -
Medtronic faces key test in establishing US market for renal denervation
After a setback six years ago, the medtech giant is set to unveil pivotal trial data next month on a procedure to lower blood pressure. Abbott and Boston Scientific are likely watching closely.
By Susan Kelly • Feb. 10, 2020 -
Abiomed, on defense, plans wave of trials to counter Impella criticism
The maker of the heart pump is seeking to quash doubts after two large observational studies suggested the product was more risky and pricey than alternative treatments.
By Nick Paul Taylor • Feb. 6, 2020 -
5-year Edwards results: TAVR matches surgery on survival, but repeat hospitalizations more common
Separately, a pair of cardiologists in an editorial published this week in the journal Circulation noted potential "important differences" between Edwards' Sapien 3 and Medtronic’s CoreValve devices.
By Nick Paul Taylor , Maria Rachal • Jan. 30, 2020 -
Abiomed device controversy revived in Circulation editorial
Experts flagged key limitations in a study suggesting the Impella device is pricier and more dangerous than intra-aortic balloon pumps, and highlighted an "urgent need" for randomized clinical trials.
By Nick Paul Taylor • Jan. 29, 2020 -
After subdued year for new spinal cord stim tech, industry seeks 2020 rebound
Medtronic, Abbott, Boston Scientific and others that presented at the North American Neuromodulation Society meeting hope an influx in new products will help restore market growth.
By Maria Rachal • Jan. 27, 2020 -
Study of Abbott's HeartMate 3 points to single treatment indication for LVADs
A study in JAMA Cardiology suggests it's unnecessary to group heart failure patients by transplant eligibility, which one cardiologist said could allow physicians to sidestep difficult upfront decisions about transplants and pumps.
By Nick Paul Taylor • Jan. 16, 2020 -
FDA OKs Abbott clinical trial of MitraClip in moderate risk patients
The transcatheter mitral valve repair device, used to treat primary mitral regurgitation, is currently only indicated for patients at a prohibitive risk for surgery.
By David Lim • Jan. 13, 2020 -
Study links paclitaxel devices to better survival in PAD, muddying debate
New research comes about six months after FDA held an advisory panel in response to a meta-analysis that found an increased risk of death associated with the use of coated balloons and stents in an artery of the lower limbs.
By David Lim • Jan. 9, 2020 -
Dive Awards
The MedTech Dive Awards of 2019
From TAVR's takeoff to FDA's new approaches to premarket review, these are the industry forces that left their mark on medical technology this year.
Dec. 9, 2019 -
Boston Scientific afib device effective in reducing stroke
Authors in the Journal of the American College of Cardiology said the rate of hemorrhagic stroke observed in left atrial appendage closure device registries is the lowest identified in the nonvalvular atrial fibrillation population.
By Nick Paul Taylor • Dec. 5, 2019 -
MRI screening linked to improved detection of breast cancer
The New England Journal of Medicine study found fewer cases of cancer are missed when MRIs are performed. At the same time, the scans come with a high rate of false positives, calling the utility of additional imaging into question.
By Nick Paul Taylor • Dec. 2, 2019 -
In stents v. statin debate, analysts call potential impact of ISCHEMIA trial overhyped
The study seemed to favor a conservative approach to treating stable heart disease. But many sell-side analysts called results expected, predicting they won't meaningfully hurt sales for device makers like Boston Scientific.
By Maria Rachal • Nov. 18, 2019 -
J&J reports rising success rate in robotic surgery clinical trial
The study is assessing diagnostic abilities of the Monarch robotic surgery platform, which Johnson & Johnson gained in the $3.4 billion acquisition of Auris Health.
By Nick Paul Taylor • Oct. 24, 2019 -
Experimental cancer IVD trial guidance finalized
AdvaMed won many many of the changes it sought during the comment period, including ones related to communication with the FDA.
By Nick Paul Taylor • Oct. 10, 2019 -
Intersect ENT misses endpoint on chronic sinusitis DCB, sending shares down
The company is "disappointed" the steroid delivery device, which it hopes to submit for premarket approval to FDA, did not prove superior on frontal sinus patency at 30 days when randomized against an uncoated balloon.
By Maria Rachal • Oct. 7, 2019 -
Edwards shows improved quality of life, durability of TAVR systems in trio of studies
Among other data presented over the weekend at TCT, Boston Scientific's in-development Acurate Neo TAVR system failed to meet a non-inferiority goal on safety and efficacy when compared to Edwards' Sapien 3.
By Susan Kelly • Sept. 30, 2019 -
Abbott's MitraClip outperforms medical therapy in study at 3 years
In addition, a group of patients that began the study on medical therapy and crossed over to the MitraClip at two years saw benefits matching those who received the device from the start.
By Susan Kelly • Sept. 30, 2019 -
Medtronic, Boston Scientific share data on stents with short-course antiplatelet therapy
The clinical trials provide data supporting the use of shorter regimens in coronary stent patients.
By Nick Paul Taylor • Sept. 27, 2019 -
Boston Scientific and Medtronic devices match on safety in 3-year TAVR trial
The Boston Scientific-backed trial found a similar rate of all-cause mortality between the two systems. Boston's device beat Medtronic's on rate of disabling stroke, but had more patients receiving a new pacemaker.
By Nick Paul Taylor • Sept. 26, 2019 -
FDA tries to spur patient shaping of clinical trial design with draft guidance
"Patient experiences and insight can help us understand the benefits most important to patients and what risks patients may or may not be willing to tolerate," acting FDA Commissioner Ned Sharpless said in a statement.
By Nick Paul Taylor • Sept. 24, 2019 -
Adaptive lands deal to provide NGS-based cancer tests to Amgen
The giant biotech will pay annual development fees, sequencing payments and regulatory milestones that could amount to a notable source of revenue for Adaptive.
By Nick Paul Taylor • Sept. 19, 2019 -
Mesh as good as hysterectomy for prolapse, 3-year NIH data suggests
The latest clinical trial outcomes appear in JAMA five months after FDA said mesh manufacturers had failed to prove adequate safety and effectiveness of the devices in patients with pelvic organ prolapse.
By Maria Rachal • Sept. 18, 2019 -
Apple to start trio of research studies on hearing, heart and women's health
The studies, which will be organized through a new Apple Research app this fall, are being conducted in partnership with various universities, hospitals, associations and the U.S. government.
By David Lim • Sept. 11, 2019 -
Physicians push FDA to shed light on device comparators
In a paper published in JAMA Network Open on Wednesday, physicians analyzed evidence used in the authorizations of products under the Humanitarian Device Exemption pathway.
By Nick Paul Taylor • Sept. 11, 2019