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 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 […]
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 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 […]
(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 […]
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.
The FDA granted Humanitarian Use Device approval for Sweden-based XVIVO Perfusion for its XPS tissue transport system for preserving donor lungs.
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.
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.