Bioheart T-PLS
Blood/heart pump, oxygenator, cooling system for cardiac surgery.
Approval
CE marked and ISO certified, it can be sold in Europe. 510k U.S. approval 2009.
Product Candidates
T-PLS
Bioheart AnC Bio T-PLS Twin True Pulsatile Percutaneous Life Support System.
Product Features:
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Tubular occlusion system for mechanical cardiac assistance. |
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Used during cardiopulmonary bypass, a process during which the function of the heart and lungs is temporarily taken over during surgery, maintaining the circulation of blood and oxygen throughout the body. |
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Unique in its ability to generate pulsatile blood flow without the help of any additional devices. |
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System consists of a pulsatile pump console, a pair of disposable pump heads and a blood tubing circuit. |
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Each disposable pump head contains two floating polyurethane valves. |
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The working mechanism of the pump head is similar to the natural heart ventricles with a maximum pump flow of seven litres per minute. |
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Currently commercially available in Korea and China and to date Bioheart’s partner in Korea (AnC Bio) has sold 38 units which up to January 2008 had been used on 250 patients. |
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CE marked and ISO certified, it can be sold in Europe. |