CEO, Sunshine Heart, Inc
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Sunshine Heart says the US FDA approved a reimbursement category for its C-Pulse heart assist trial, opening Medicare reimbursement; it retained Quorum Consulting and expects patient enrollment at six US institutions in late 2008.
US regulators have conditionally cleared Sunshine Heart to begin its first American trial of the C-Pulse heart assist device in moderate heart failure patients, with enrollment at six institutions.
Sunshine Heart says the US regulator has conditionally cleared its first American trial of the C-Pulse heart assist device, with about twenty patients to enrol across six US hospitals from late 2008.
A heart-device company has finished building an updated portable driver for its C-Pulse therapy system with a US manufacturing partner, completing preclinical work ahead of an American trial and regulator filing planned for 2007.
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ASX-listed heart device maker Sunshine Heart has finished training clinicians at six US hospitals ahead of its C-Pulse feasibility trial, planned to start later in 2007.
Medical device company Sunshine Heart has contracted US research organisation Alquest to manage its North American clinical trial of the C-Pulse heart assist device.
Two American heart failure specialists have agreed to serve as co-principal investigators for Sunshine Heart's C-Pulse feasibility trial, which the company says adds credibility as it prepares a wider US study in 2007.
Sunshine Heart says co-founder Crispin Marsh will swap his executive corporate affairs role for a non-executive board seat from mid-2006, as the medical device maker brings in senior staff including a new COO.
Medical device firm Sunshine Heart closed a roughly A$3.3 million placement to institutional investors, funding its clinical trial and C-Pulse driver work; the release also cites an earlier A$2.2 million Commercial Ready grant.
Medtech company Sunshine Heart has brought in Ruth Flynn as its first clinical affairs manager, to drive C-Pulse heart assist device trials across Australia and New Zealand from its Sydney head office.
ASX-listed medical device company Sunshine Heart appointed Melbourne heart transplant specialist Professor Don Esmore to its medical advisory board, which already includes academics from Penn State, Stanford and the Cleveland Clinic.
Surgeons in Auckland have placed the C-Pulse cardiac support device from Australian medtech Sunshine Heart into a patient for the first time, with further trial sites planned at Australian hospitals.