Heater-cooler devices are used during surgeries to cool or warm patients depending on their case. The heart cooler devices forms an important part of surgeries related to lungs and heart. Heater-cooler devices include tanks that provide temperature-controlled water to external heat exchangers or to warming/cooling blankets through closed water circuits. Heater-cooler devices are Class II devices that can be included under one of the following cardiovascular classification regulations: 870.4250 Cardiopulmonary Bypass Temperature Controller or 870.5900 Thermal Regulating System.
Heater-Cooler Devices Market: Drivers and Restraints
The demand for heater-cooler devices is expected to boom owing to the increasing number of heart surgeries that are performed. With every year, the volume of heart surgeries as the number of people with the occurrence of such heart diseases is also increasing. Moreover, in emerging economies such as India, heart disease is on its way to becoming an epidemic in the country.
Heater-Cooler Devices Market: Overview
The cardiopulmonary bypass temperature controller is used to supply temperature controlled water to the heat exchange devices intended to supply temperature controlled blood to the type of surgery being performed. Thermal Regulating Systems are used with cooling/warming devices. Though these heater-cooler devices fall under the cardiovascular class of regulation, they can be used for other medical procedures. According to the CDC, every years there are around 250,000 heart by-pass surgeries performed in the U.S. The heater cooler-devices form a very important part of life saving surgeries as they maintain the temperature of the circulating blood or the organ.
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Heater-Cooler Devices Market: Region-wise Outlook
In terms of geography, heater-cooler devices market has been divided into seven regions including North- America, Eastern Europe, Western Europe, and Asia- Pacific excluding Japan, Japan Middle-East & Africa and Latin America. The heater-cooler devices market is dominated by North America region while Asia Pacific is expected to emerge as a fastest growing region. In October 2015, the U.S. FDA had issued safety communications related to heater-cooler devices to help reduce the risk of infection to patients. The document included certain recommendations related to the use of the heater-cooler devices to minimize the changes of nontuberculous mycobacterium infections.
Heater-Cooler Devices Market: Key Market Participants
Some of the heater-cooler devices market participants are Terumo Corporation., Sorin Group and CardioQuip, among others. The potential offered by the heater cooler devices has led to the improvement of the current product offerings offered. Market players manufacturing the heater-cooler devices are modifying their existing heater-cooler devices and applying for approvals. This trend is expected to create a market for heater-cooler devices where there is a demand for upgraded products and the market players are also developing the heater-cooler devices to compete with the rest. In August 2017, Livanova PLC announced the implementation of a device modification to its existing 3T Heater-Cooler devices in Western Europe. The modification of the heater-cooler device offered to the customer comes at no cost. The heater-cooler device available to the customer was upgraded with the installation of an internal sealing and vacuum system.
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LivaNova plans to implement the design modification on existing heater-cooler devices in the field, as one part of a three-part device remediation plan to address the important industry-wide issue concerning the use of heater-coolers during open-heart surgery.