An FDA advisory panel yesterday recommended that the federal safety watchdog approve a device made by TransMedics to keep donated lungs perfused during transport to transplantation procedures. The FDA’s Gastroenterology & Urology Devices panel voted 11-2 that the OCS Lung system is safe; 8-5 that it’s effective; and 9-4 that its benefits outweigh the risks, an FDA spokeswoman told […]
TransMedics launches pivotal trial for OCS liver transplant system
TransMedics said today that it launched a pivotal study of its OCS Liver device, which is designed to keep donated human liver warm and perfused until transplantation. Andover, Mass.-based TransMedics said the 1st liver transplantation using OCS Liver was performed at Mass. General Hospital by Dr. James Markmann, a lead investigator for the 300-patient OCS Liver […]
TransMedics wins FDA panel date for organ preservation device
The FDA plans to convene an advisory panel to review the pre-market approval bid for the organ preservation device made by TransMedics. The FDA’s Gastroenterology & Urology Devices panel is slated to meet Nov. 18 to discuss Andover, Mass.-based TransMedics’ PMA bid for its Organ Care System, which is designed to perfuse a donor heart with warm, oxygenated blood and monitor its status until […]
TransMedics raises $20m for ‘heart-in-a-box’
TransMedics raised a $20 million funding round for its organ preservation and transportation device, according to a regulatory filing. Eleven unnamed investors participated in the round for Andover, Mass.-based TransMedics, according to the filing. The TransMedics organ care system is designed to perfuse the heart or other organs with warm, oxygenated blood, continuously monitoring their status until […]
Doctors perform historic skull-and-scalp transplant surgery
(Reuters) — A man whose cancer left him with severe damage to the top of the head received what his doctors in Houston describe as the 1st skull-and-scalp transplant, the MD Anderson Cancer Center said yesterday. James Boysen, a 55-year-old software developer from Austin, received the craniofacial tissue transplant at the same time as a […]
San Francisco hospital begins rare 6-way kidney transplant chain
TransMedics heart preservation system used in Aussie transplants
Transmedics said surgeons in Australia used its organ care system to preserve and assess a trio of hearts from donors whose organs had stopped beating, before the hearts were successfully transplanted.
XVIVO Perfusion wins FDA approval for donor lung transport system
The FDA granted Humanitarian Use Device approval for Sweden-based XVIVO Perfusion for its XPS tissue transport system for preserving donor lungs.
Press Release: FDA approves donor lung preservation device that may result in more lung transplants
FDA sets a date to review XVIVO’s lung perfusion system
Sweden-based XVIVO Perfusion landed a date with the FDA to review Humanitarian Device Exemption for its XVIVO Perfusion System for preserving donor lungs.
XVIVO will meet on March 20 with the FDA’s Gastroenterology & Urology Devices Panel to review data on the device, which provides continuous perfusion of otherwise unacceptable lung tissue, allowing clinicians to reevaluate the organs for transplantation.
Cali biotech promises a 3D-printed organ this year | MassDevice.com On Call
MASSDEVICE ON CALL — California biotech startup Organovo has its sights set high, promising to demonstrate the promise of 3D bio-printing technology by unveiling a human organ made of printed living cells by the end the year.
Organovo plans to begin organ-printing with the human liver, constructed by laying down layer after layer of human tissue to form a single organ. To do so, the company needs to develop a sort of vascular system to keep the organ fed with nutrients and oxygen, lest it wither on the printer.