Paragonix Technologies said today that the FDA granted 510(k) clearance for a design change to its SherpaPak heart transport device so that it can be used with small and pediatric hearts. Braintree, Mass.-based Paragonix said it will begin shipping heart connectors covering most aortic diameters during the first quarter of 2019. “This FDA clearance is an […]
Paragonix touts performance of donor-heart transport technology
Paragonix Technologies (Braintree, Mass.) said today that its SherpaPak donor-heart transport system has been used successfully at Massachusetts General Hospital in Boston and other transplant centers around the U.S. and Europe. The SheraPak combines cooling technology with safe, consistent methods for cold ischemic storage and transport of donor organs, according to the company, which is […]
3D-printed corneas could save millions’ vision
British scientists have 3D printed the first human corneas, yielding a potential fix to the worldwide shortage of corneas for implantation. The Newcastle University researchers created a bio-ink using stem cells from a healthy donor cornea mixed with alginate and collagen. They used a simple, low-cost 3D bio-printer to extrude the bio-ink in concentric circles to form […]
Could this system make more kidneys, livers usable for transplant?
An Italian startup has teamed with critical-care immunotherapy company CytoSorbents Corporation (NASDAQ: CTSO) on an integrated ex-vivo system to perfuse, cleanse, recondition and preserve harvested kidneys and livers — including those that are usually discarded. Aferetica srl (Mirandola, Italy) designed its PerLife system is to improve organ function and viability while reducing the risk of primary graft failure and […]
Paragonix Technologies aims to boost survival of donated lungs
Many lungs being transported for transplant arrive in such bad shape that they cannot be used. Paragonix Technologies, Inc. aims to change that with SherpaLung, a specialized cooler that keeps lungs properly inflated and at the right temperature to survive an airplane trip. Paragonix Technologies just landed support from the Lung Transplant Foundation to continue developing […]
TransMedics wins FDA approval for OCS Lung transplant system
TransMedics said today that it won pre-market approval from the FDA for its OCD Lung transplant system, which is designed to keep donated human lungs in near-living condition until transplantation. The March 22 approval covers standard double-lung transplantation procedures, Andover, Mass.-based TransMedics said. The federal safety watchdog granted the PMA based on data from the 316-patient […]
Paragonix Tech wins CE Mark for heart transport devices
Paragonix Technologies said today it won CE Mark approval in the European Union for its SherpaPak and SherpaPerfusion cardiac transport systems. The SherpaPak system consists of a single-use, disposable device designed for the hypothermic static preservation and transportation of the donor hearts, while the SherpaPerfusion system is a single-use, disposable device designed for hypothermic oxygenated […]
Engineered tissue could eliminate radiation for bone marrow transplants
University of California San Diego engineers have created artificial bone tissue that could eliminate the need for radiation before bone marrow transplants. Shyni Varghese, a bioengineering professor at UC San Diego Jacobs School of Engineering, led a team to develop a bone-like implant to eliminate the pre-treatment radiation that kills stem cells in a patient’s bone […]
Smithfield to explore pig-human transplants
The world’s largest pork producer, Smithfield Foods, has reportedly launched a bioscience unit to expand its role in supplying pig parts for medical uses. The unit’s ultimate goal is to sell pig organs for transplantation into humans. Although pig-human organ transplants are years away, recent scientific advances are helping scientists overcome obstacles that halted prior […]
FDA warns of contaminated organ preservation solution
The FDA today warned of issues associated with contaminated SPS-1 static organ preservation solution from Organ Recovery Systems. The solution is intended for the flushing and cold storage of the kidney, liver and pancreas at the time of organ removal from the donor to prep for storage, transportation and eventual transplantation. Staff at a healthcare […]
Here’s how you heat up cold hearts—for transplantation
A University of Minnesota–led research team has successfully warmed large-scale animal heart valves and blood vessels that were previously preserved at low temperatures. The discovery of this rewarming process is pivotal for organs and tissues that are left in storage for transplantation for extended periods. “This is the first time that anyone has been able […]
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