News & Events

Global Transplant Solutions Canada Gains Health Canada Clearance

servator P & Servator C Health Canada Clearance

Global Transplant Solutions Canada gains Health Canada Clearance for two Organ –Specific Preservation Solutions MedDevice International. Global Transplant Solutions-Canada of Toronto, Ontario, a Division of Global Transplant Solutions Inc. (GTS), of Duncan, South Carolina announced receipt of Health Canada clearance for two more Organ-specific Preservation Solutions, Servator P® Lung Preservation Solution and Servator C® Cardiac Preservation Solution.  Both products were cleared under Health Canada’s Interim Policy Directive for Organ Perfusion Solutions.  Servator P® Solution is cleared...

Deceased Organ Donors in U.S. Exceeds 10,000

2017 Transplants

Deceased Organ Donors in United States Exceeded 10,000 for first time in 2017 MedDevice International. Organ donation in the United States saw an accelerated increase in 2017. https://unos.org/deceased-organ-donors-in-united-states-exceeded-10000-for-first-time-in-2017/ Back to News &...

Organ Donation Surging in Canada

MedDevice International. The number of organ donations from deceased Canadians has surged in recent years, boosted by improvements in the organ donation system. https://www.theglobeandmail.com/life/health-and-fitness/health/deceased-organ-donations-are-surging-in-canada-data-show/article37323099/ Back to News &...

Global Transplant Solutions, Inc. Receives FDA Clearance

FDA Clearance

Global Transplant Solutions, Inc. Receives FDA Clearance for an Organ Preservation Solution MedDevice International. Global Transplant Solutions, Inc. (GTS), of Duncan South Carolina, announced receipt of FDA clearance for Servator H® HTK Organ Preservation Solution (Bretshneider’s Histidine-Tryptophan-Ketoglutarate solution). Servator H® is cleared for the flushing, preservation and storage/shipping of kidneys, liver, pancreas, and heart for transplant.  GTS will start supplying Organ Procurement Organizations and transplant centers in the US with Servator H® HTK in 2018. All GTS...

Health Canada Clearance for Two New Organ Preservation Solutions

Global Transplant Solutions-Canada gains Health Canada Clearance for two Organ Preservation Solutions MedDevice International. Global Transplant Solutions-Canada of Toronto, Ontario, a Division of Global Transplant Solutions Inc. (GTS), of Duncan, South Carolina announced receipt of their first Health Canada clearance for two Organ Preservation Solutions, Servator B® UW Organ Preservation Solution (University of Wisconsin solution) and Servator H® HTK Organ Preservation Solution (Bretshneider’s Histidine-Tryptophan-Ketoglutarate solution).  Both products were cleared under Health Canada’s...

Essential Pharmaceutical and Custodial® Purchased by Accord Healthcare of India.

Accord Healthcare

MedDevice International. Essential Pharmaceuticals of Ewing New Jersey, the primary distributor of Custodial® Organ Preservation Solution, was acquired by Accord Pharma, the US arm of the India-based generic pharmaceutical firm, Ista. https://www.prnewswire.com/news-releases/accord-healthcare-announces-acquisition-of-essential-pharmaceuticals-300493990.html https://americanpharmacynews.com/stories/511162859-accord-acquires-rights-to-sell-custodiol-htk-solution https://www.accordhealthcare.us/about Back to News &...

Belzer UW® makers issued a FDA Warning Letter

FDA Organ Preservation Solution Warning

Preservation Solutions Inc., Maker of Belzer UW®, Issued a FDA Warning Letter MedDevice International. Preservation Solutions Inc., of Ekhorn Wisconsin, the manufacturer of University of Wisconsin solutions marketed by Bridge to Life of Columbia, SC, has been issued a FDA Warning letter, and follow up warnings after Inspections found serious infractions and a lack of adherence to mandated GMP (General Manufacturing Practices) guidelines. https://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2017/ucm575367.htm...

Organ Recovery Systems Under FDA mandated product Recall of SPS-1

FDA Organ Preservation Solution Recall

MedDevice International. Organ Recovery Systems, the makers of the LifePort® Kidney perfusion system and a supplier of SPS-1® Organ Preservation Solution continues to be plagued with serious manufacturing issues, and remains under an FDA Warning following the identification of several poor grades from FDA inspections. https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRes/res.cfm?ID=151877 https://www.fda.gov/MedicalDevices/Safety/AlertsandNotices/ucm545810.htm https://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2017/ucm555755.htm...

Global Transplant Solutions' products meet all the QUALITY STANDARDS set by the US FDA, the European Union Health Ministry, and Health Canada.

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