Cardica gains CE mark for improved anastomosis system:
This article was originally published in Clinica
Executive Summary
Cardica has CE marked its C-Port Flex A Anastomosis System, a device designed to facilitate minimally-invasive coronary artery bypass graft (CABG) surgery, for sale in Europe. The product is a variation on a previously approved Cardica product, the C-Port xA Distal Anastomosis System. Its advantages over the earlier version include a flexible shaft intended to better allow surgeons to join blood vessels in hard-to-reach areas of the heart. The Redwood City, California, company claims that it can create anastomoses in vessels as small as one millimetre in internal diameter, and can be used in either on- or off-pump CABG procedures. The Flex A received 510(k) clearance from the US FDA in March 2007 (see Clinica No 1253, p 24).
You may also be interested in...
Organon And Henlius Complete Phase III For Denosumab
Having earlier this year reported positive Phase I data for their partnered denosumab biosimilar candidate, Organon and Shanghai Henlius Biotech have now announced that their HLX14 version has met primary endpoints in a Phase III study.
Taro Agrees $36m Securities Settlement Over US Price-Fixing Claims
Sun’s Taro subsidiary is looking to move forward with an eight-figure settlement deal in the US, after plaintiffs including a firefighters’ pension fund accused the firm of misleading investors via its involvement in generic price fixing, leading to a fall in the price of its securities.
As Casgevy, Lyfgenia Launches Proceed, CRISPR And bluebird bio CEOs Reassure
The CEOs of bluebird bio and CRISPR Therapeutics hope to inspire investor confidence that their gene-based therapies for sickle cell disease and beta thalassemia will be widely reimbursed in the US and EU.