A Medical Device Daily

TransMedics (Andover, Massachusetts) reported receiving CE marking for its Organ Care System, which it calls “the first and only system that allows human donor organs to be maintained in their normal functioning state outside the human body.”

TransMedics says that its Organ Care System maintains donor organs in “a physiologic functioning state outside the human body to optimize their health and to allow real time ex vivo clinical evaluation of donor organs for the first time.”

Warm, oxygenated blood is perfused through the organ from the time of removal until it is implanted, maintaining organs in a warm, functioning state outside the body until ready for implantation.

As compared to cold storage or cold perfusion techniques, TransMedics says that the Organ Care System “may allow the organ to withstand longer periods of time outside of the body and experience less damage resulting from lack of blood supply to the organ during transportation to the recipient.”

“The Organ Care System addresses the vital need for a solution to the global shortage of organs available for end-stage organ failure patients. This designation is an important commercialization milestone for us and an essential step toward providing European physicians and patients with improved options for organ transplant,” said Dr. Waleed Hassanein, founder and president/CEO of TransMedics.

Organ Care System is aimed at providing cost benefits to the healthcare system by reducing the time patients need to be maintained on bridge therapies while waiting for a donor organ, ensure more rapid recovery and reduced hospital stays following transplantation, as well as reduce both the need for medical therapy to treat complications and the need for re-transplantation.

The company said that those requiring transplants continues to rise faster than the number of available donors.

Of the 12,000 people in Germany currently waiting for a donor organ, only a third will receive a transplant. Nearly 1,000 transplant candidates die each year.

In the UK, 6,000 patients are waiting for an organ transplant. However, fewer than 3,000 transplants are carried out annually; thus the transplant list continues to get longer. Unfortunately, more than half of all hearts that have been consented for donation still go unused.

The limits of current cold preservation methods contribute to this problem, the company says, and that the situation is equally serious in the U.S.

It says that of the 89,000 people in the U.S. currently waiting for a donor organ, only a third will receive a transplant, while nearly 7,000 will die each year while waiting for an organ.

FASTlab showcased at Athens meeting

GE Healthcare (Waukesha, Wisconsin), at the Annual Congress of the European Association of Nuclear Medicine (Vienna) in Athens, Greece, showcased its new, high-performance chemistry system, FASTlab, designed to streamline positron emission tomography (PET) radiopharmaceutical production. The new platform, it said, “features a single-use cassette system that enables PET diagnostics to become more accessible to patients.”

“FASTlab demonstrates the unique technical and chemical expertise within GE Healthcare. The depth of knowledge we have in both engineering and chemistry has made this breakthrough technology possible,” said Daniel Peters, president/CEO Medical Diagnostics at GE Healthcare.

FASTlab’s performance for Fluorodeoxyglucose (FDG) synthesis was successfully tested at commercial distribution and academic sites in the U.S. and Europe, GE Healthcare said. The cassette platform was shown to produce batches of FDG with a mean uncorrected yield of 70% (equivalent to 81% corrected yield) as reported by Professor Val Lowe and Mark Jacobson from Mayo Clinic (Rochester, Minnesota), Professor Andre Luxen from the University of Liege (Liege, Belgium), and Richard Sheriff, president of Shertech Laboratories (Easley, South Carolina).

FASTlab’s single-use cassette contains pre-measured quantities of all chemicals needed for the synthesis of radiopharmaceuticals accounting for its high yield and high reproducibility.

“FASTlab’s cassette-based mechanism and ease of use will bring turn-key production of PET tracers a step closer,” said Lowe.

FASTlab is designed to accommodate different chemistries, facilitating the production of multiple PET tracers. The first application launched on the platform is FDG, the most widely used PET radiopharmaceutical today. GE Healthcare is planning to expand the utility of the platform by developing a range of other radiopharmaceuticals, including GE Healthcare proprietary diagnostic imaging agents.

According to Jim Mitchell, General Manager of GE Healthcare’s Global Radiopharmacy Systems unit, FASTlab establishes a new standard of efficiency for commercial PET radiopharmacies and researchers at the clinical stage of PET tracer development.

“PET is an excellent tool to provide quantitative diagnosis of disease at the cellular and molecular level,” Mitchell said. “However, a limitation of PET is the massive infrastructure and scarce expertise that is required for radiopharmaceutical production. FASTlab makes radiopharmaceutical production much easier and thus may help PET diagnostics to become more accessible to patients.”

Radlink, Ado-Med partner in Europe

Radlink (Redondo Beach, California) a provider of medical imaging systems to healthcare, said that it has signed an agreement to extend its partnership with Ado-Med (Portland, Oregon), a medical services company.

Ado-Med will serve as exclusive distributor for Radlink products in the European Union, Russia and the Ukraine.

Ado-Med will also establish a European service center for Radlink’s CR Pro machine, which utilizes sealed fiber-optic laser technology to deliver “high-resolution, diagnostic-quality images at a fraction of the cost of other computed radiography machines on the market,” the company said.

“Ado-Med has been a crucial partner for us in gaining a foothold in Europe, leading the way for us to quickly accelerate sales of CR Pro throughout the large and promising Eastern European healthcare marketplace,” said Thomas Hacking, Radlink CEO.