NEWS & EVENTS

GTS exhibits at AOPO 2018 Annual Meeting

June 18-20 2018

GTS exhibits at AOPO 2018 Annual Meeting.

http://www.aopo.org/annual-meeting/

Global Transplant Solutions Canada Gains 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 for the flushing, perfusion, preservation, and storage/shipping of procured lungs for transplant. Servator C® is cleared for the flushing, preservation, and storage/shipping of procured hearts for transplant.   All GTS products are manufactured by SALF spa at their GMP/ISO/Health Canada certified sterile solutions manufacturing facility located outside of Bergamo, Italy.

Global Transplant Solutions- Canada distributes all their products from a Canada-dedicated medical product distribution center in Melville, Ontario.

Global Transplant Solutions, Inc. Receives 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 products are manufactured by SALF spa at their GMP/ISO/Health Canada certified sterile solutions manufacturing facility located outside of Bergamo, Italy.

GTS will distribute all products from their headquarters, warehouse and distribution center located in Duncan, SC.

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 Interim Policy Directive for Organ Perfusion Solutions.  Servator B® UW Organ Preservation Solution is cleared for the flushing, preservation and storage/shipping of kidneys, liver, and pancreas for transplant.  Servator H® HTK is cleared for the flushing, preservation, and storage/shipping of procured kidneys, liver, pancreas, and hearts for transplant.   All GTS products are manufactured by SALF spa at their GMP/ISO/Health Canada certified sterile solutions manufacturing facility located outside of Bergamo, Italy.

Global Transplant Solutions- Canada will distribute all their products from both a Canada-dedicated medical product distribution center in Melville, Ontario, as well as GTS-Canada’s Offices in Downtown Toronto.

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

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

Belzer UW® makers issued a FDA Warning Letter

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

https://www.fdanews.com/articles/183722-preservation-solutions-draws-fda-warning-for-gmp-violations

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

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

http://www.empr.com/safety-alerts-and-recalls/organ-kidney-liver-pancreas-transplant-preservation/article/643194/

http://www.ishlt.org/ContentDocuments/2017JanLinks_Pouch.htm

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