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April 28, 2016

HeartWare completes enrolment in lateral study for HVAD system

US-based company HeartWare, a developer of miniaturised implantable cardiovascular devices, has completed the patient enrolment in the HeartWare ventricular assist system (HVAD system) lateral study.

US-based company HeartWare, a developer of miniaturised implantable cardiovascular devices, has completed the patient enrolment in the HeartWare ventricular assist system (HVAD system) lateral study.

Lateral is a US investigational device exemption (IDE) prospective, multicentre, single-arm clinical trial which will include up to 145 patients at more than 30 hospitals in North America.

The trial is designed to evaluate the outcome of patients with end-stage heart failure, awaiting a heart transplant, using an implant with the HVAD Pump through a less-invasive thoracotomy procedure.

"This less invasive surgical technique also benefits patients by delaying the need for full sternotomy until cardiac transplantation, enabling an easier surgical procedure at the time of transplant."

University of British Columbia, Department of Surgery, Division of Cardiovascular Surgery Clinical Professor of Surgery and Hvad Lateral study co-principal investigator Anson Cheung said: "Clinical data from the lateral study has the potential to confirm the observations from prior, single-centre studies evaluating the thoracotomy technique and to help facilitate a discussion of innovative surgical implantation techniques to achieve optimal patient outcomes."

Approved by the US Food and Drug Administration (FDA) in 2012, the HVAD System is said to feature the world’s smallest full-support circulatory assist device, the HVAD Pump.

It is implanted next to the heart through a small, lateral thoracotomy incision between the patient’s ribs on the left side of the chest, avoiding abdominal surgery.

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Loyola University Stritch School of Medicine department of thoracic and cardiovascular surgery professor and heart transplant and assist device programme head Ed McGee said: "This less invasive surgical technique also benefits patients by delaying the need for full sternotomy until cardiac transplantation, enabling an easier surgical procedure at the time of transplant.

"We look forward to monitoring patients through the six-month follow-up period and then reviewing the trial results to help inform the medical community about the potential benefits of the thoracotomy implantation technique."

The HVAD System is used by more than 10,000 patients with advanced heart failure across 47 countries.

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