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Implants

Cochlear protests Medicare exclusion of Baha hearing implant

July 24, 2014 by Arezu Sarvestani

Hearing devices maker Cochlear Limited warns that Medicare's proposed rule change could limit access to certain cochlear implants.

Device maker fights Medicare bump for hearing aids

A proposed change to Medicare's reimbursement of hearing aids could leave patients on their own when they need the a specific type of bone-anchored hearing aid implant, according to device maker Cochlear Ltd. (ASX:COH).

FDA rejects ban on pelvic mesh, supports reclassification

July 16, 2014 by Arezu Sarvestani

FDA medtech regulators decline a citizen petition to ban transvaginal mesh implants in the U.S., but "tentatively" agree that a reclassification may be in order to put the devices under more regulatory scrutiny.

FDA rejects ban on pelvic mesh

FDA regulators refused this week to ban U.S. sales of pelvic mesh implants, rejecting in large part a petition filed by consumer advocacy group Public Citizen, but offered some consolation in a potential reclassification of the devices to a higher-risk category.

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Valve-in-valve surgery shows promise in new registry study

July 11, 2014 by Arezu Sarvestani

An new study shows that transcatheter aortic valve-in-valve implantation may be an important option for a growing population of patients with deteriorating bioprosthetic implants, but outcomes depend strongly on how the previous valve is failed.

Medtronic and Edwards implants show promise in valve-in-valve treatment

New research released this week provides more support for the use of transcatheter aortic valve-in-valve (VIV) implantation as a means of replacing previously implanted valves that have deteriorated over time.

More good news for Abbott's MitraClip in JACC study

July 11, 2014 by Arezu Sarvestani

Abbott's MitraClip implant reduces mitral regurgitation and improves quality of life at 1 year in high-risk patients, according to new study results from the Everest II clinical trial.

More good news for Abbott's MitraClip

High-risk patients with mitral regurgitation reduced their symptoms and reported better quality of life after treatment with Abbott's (NYSE:ABT) MitraClip implant, according to newly published results from the Everest II High Risk Registry.

Smith & Nephew enters robotics with knee surgery partnership

July 10, 2014 by Arezu Sarvestani

Smith & Nephew integrates its partial knee implants with Blue Belt Technologies' Navio robot-assisted surgical system.

Smith & Nephew enters the robotics arena

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Study: Early CoreValve patients saw growing leakage, mortality risk

July 1, 2014 by Arezu Sarvestani

Valve leakage and cardiovascular mortality increased significantly over the course of a 3-year study of early high-risk patients treated with Medtronic's CoreValve TAVI system, but researchers insist the results are still "amazingly good."

Study: Early CoreValve patients plagued by side effects at 3 years

Encision gets caught in surgical mesh crossfire

June 27, 2014 by Arezu Sarvestani

Colorado device maker Encision finds itself fighting nearly 50 patient injury lawsuits related to surgical mesh products that it never manufactured or distributed.

Encision gets caught in pelvic mesh crossfire

Surgical devices maker Encision (PINK:ECIA) found itself the unfortunate target of nearly 50 lawsuits over alleged injuries caused by transvaginal mesh devices that Encision neither manufactures nor distributes.

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