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Medtronic’s Avalus surgical valve shows benefits in new study
Medtronic has announced new clinical trial data supporting the safety and effectiveness of its Avalus pericardial aortic surgical valve.
The device, which is intended for the treatment of aortic valve disease, was shown to be associated with low rates of adverse valve-related events, high survival and improved haemodynamic performance at one year in the PERIGON trial.
Involving more than 1,300 patients from 40 clinical sites across Europe, Canada, Japan and the US, the study has so far affirmed the benefits of the device, with all patients showing low rates of all-cause mortality and cardiac death after a year of treatment.
Medtronic designed the Avalus valve in close collaboration with expert surgeons, with its design concepts and contemporary features intended to help facilitate procedural ease of use, while enabling the lifetime management of the patient.
Rhonda Robb, vice-president and general manager of Medtronic's heart valve therapies business, said: "We are very pleased to see the initial positive outcomes from this trial and intend to report on the growing body of evidence at future congresses."
As yet, the Avalus valve has not received regulatory approval in the US or Europe.
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