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June 26, 2016

BioVentrix secures CE mark for Revivent TC transcatheter ventricular enhancement system

US-based medical device company BioVentrix has secured CE mark approval for its Revivent TC transcatheter ventricular enhancement system used for myocardial infarction or heart attack.

US-based medical device company BioVentrix has secured CE mark approval for its Revivent TC transcatheter ventricular enhancement system used for myocardial infarction or heart attack.

The procedure offers a non-invasive alternative surgery which involves the implantation of small titanium anchors along the outer surface of the heart and along one of the interior walls using a closed-chest, endovascular approach.

The anchors are then drawn towards one another, excluding the scarred and non-functioning heart wall which results in a reduced ventricular volume by as much as 30-40%.

"Heart failure remains an epidemic worldwide and the CE marking certification validates the need for a novel therapy."

BioVentrix chief medical officer Dr Lon Annest said: "Heart failure remains an epidemic worldwide and the CE marking certification validates the need for a novel therapy for heart failure patients suffering from left ventricular dysfunction.

"There is no doubt that LV volume reduction is an important therapy as it directly impacts the parameters that determine prognosis and survival, such as LV volume and ejection fraction.

"The impact of the Revivent TC System is achieved by transcatheter access to exclude the ischemic portion of the left ventricle from the healthy tissue."

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Patients treated with the Revivent TC System have exhibited improvements in their quality of life by 38%.

A reduction of LV end-systolic volume index (31%) and improvement of LV ejection fraction (23%) have also proven to be instrumental in extending the life of the patients.

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