Stanford spin-out Fibralign announced today that it entered into a long-term distributor agreement with Terumo for the BioBridge collagen matrix. The agreement is set to see Terumo market and distribute BioBridge collagen matrix, which is used to treat and prevent secondary lymphedema, in Japan. BioBridge is a sterile, implantable, biocompatible and biodegradable surgical mesh made […]
Terumo Aortic gains FDA breakthrough designation for aortic arch repair device
Terumo Aortic this week said it received FDA breakthrough device designation for its Thoraflex Hybrid stented device for complex aortic arch repair. Thoraflex Hybrid is a single-use device that combines a gelatin-sealed woven polyester graft with a Nitinol self-expanding stent graft. It is designed for the surgical repair or replacement of damaged or diseased aortic […]
Terumo, Marker Therapeutics win emergency nod for blood-treatment system
The FDA has issued emergency use authorization (EUA) to Terumo BCT (OTC:TRUMY;TYO:4543) and Marker Therapeutics for a blood purification and oxygenation system to treat patients with COVID-19. Lakewood, Colo.-based Terumo’s Spectra Optia apheresis system works with the Depuro D2000 adsorption cartridges made by Marker Therapeutics to reduce the number of cytokines and other inflammatory blood […]
Stent makers point to quality-of-life findings by massive federal study
The giant federal study that found the use of stents in stable heart-disease patients is no better than drugs to treat clogged arteries reached another, less-hyped conclusion. Manufacturers of stents for percutaneous coronary intervention (PCI) note that the Ischemia study also concluded that patients who undergo a stenting procedure have a better quality of life. They suffer […]
Study: Stents no better than drugs for stable heart disease
This article has been updated with stock market results and comments from Medtronic. A major new study has concluded that the use of stents in stable heart disease patients is no better than drugs to treat clogged arteries. Results of the Ischemia study were released at the American Heart Association annual meeting in Philadelphia on Saturday. The […]
Orchestra BioMed wins breakthrough nod for Virtue SEB
Orchestra BioMed said today that it received breakthrough device designation from the FDA for its Virtue sirolimus-eluting balloon for the treatment of below-the-knee peripheral artery disease. The Virtue SEB is the first and only non-coated below-the-knee sirolimus-eluting angioplasty balloon system to receive a breakthrough nod, Orchestra BioMed said in a release. Get the full story […]
IceCure Medical inks distro deal with Terumo for Japan, Singapore
IceCure Medical said today that it has signed Terumo (OTC:TRUMY;TYO:4543) as the exclusive distributor of its tumor-freezing technology in Japan and Singapore. Terumo will pay IceCure $2 million for the distro rights if IceCure obtains the appropriate regulatory approvals for its ProSense cryoablation device, designed to treat malignant breast tumors without surgery. This will include […]
Report: “Unglamorous” medtech outshines biopharma in 2019
Medtech merger and acquisition deal announcements slowed in the first half of 2019, but the industry got a boost from Verily’s $1 billion round of funding — the largest ever for a medtech firm. The Verily round was twice the size of the biggest-ever VC deal for a biotech company, according to the Vantage Half-Year […]
Terumo recalls select Solopath balloon systems
Terumo (OTC:TRUMY;TYO:4543) is recalling a select number of its Solopath balloon expandable transferal system and re-collapsible balloon access systems due to issues with tip dislodgment from the sheath that could cause possible patient injuries. The FDA has labeled the recall as Class I, its most severe classification which is used when there is a reasonable probability […]
Terumo’s Microvention touts Web aneurysm embolization study
Terumo (OTC:TRUMY;TYO:4543) subsidiary MicroVention today released results from the WEB-IT pivotal trial of its Web aneurysm embolization system. Results from the trial were published in the online edition of the Journal of NeuroInterventional Surgery, the Aliso Viejo, Calif.-based company said. The trial enrolled a total of 150 patients across 21 U.S. centers and six international centers, MicroVention said. […]
Terumo’s MicroVention wins FDA approval for Web brain aneurysm device
Terumo (OTC:TRUMY;TYO:4543) subsidiary MicroVention said today that it won pre-market approval from the FDA for the Web brain aneurysm device it acquired when it bought Sequent Medical back in 2016. Aliso Viejo, Calif.-based MicroVention said the PMA for the Web embolic coil covers the treatment of intracranial wide neck bifurcation aneurysms. “We are proud to offer […]
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