World Heart Corp has received a conditional approval from U.S. health regulators to begin a clinical study of its magnetically levitated implantable heart pump, sending its shares up as much as 60%.
The study of the company's Levacor ventricular assist device has been assigned a CMS category B2 status, which makes insurance reimbursement possible.
Heart assist devices are required by patients with severely damaged hearts who need the help of an artificial heart pump while waiting for a transplant.
World Heart's Levacor is a bearingless implantable centrifugal pump that uses magnetic levitation to fully suspend the spinning rotor.
The U.S. Food and Drug Administration has asked the company to submit additional data within 45 days, but permitted the study to begin on getting approvals from the Institutional Review Board, the company said in a statement.
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