Thoratec HeartMate XVE
This article was originally published in The Gray Sheet
Executive Summary
Enhanced version of the HeartMate VE left ventricular assist system, which debuted Dec. 17 for use as a bridge to transplant, incorporates a longer, thinner lead and a rotating tunneling bullet to ease implantation of the device, as well as improved graft design to reduce kinking and increased battery life. Thoratec plans to file a PMA supplement for the XVE as an alternative-to-transplant destination therapy, pending approval of the same indication for the VE (1"The Gray Sheet" Nov. 19, 2001, p. 15)...
You may also be interested in...
Thoratec HeartMate VE LVAS Cuts Mortality Rate By 27% At One Year
A 52% one-year survival rate for patients implanted with the Thoratec HeartMate VE represents a 27% improvement over medical therapy for end-stage heart failure when the left ventricular assist system is used as an alternative to transplant
Japan Grants Global-First Approval To Zolbetuximab, 15 Other New Drugs
Astellas's first-in class CLDN18.2-targeting antibody receives its first approval worldwide, while crovalimab and a number of drugs for rare diseases also receive nods from regulators and are now awaiting reimbursement price-listing.
Hanmi-OCI Merger Hits Wall As Brothers Win Shareholder Vote, Board Seats
The planned merger of Korea's Hanmi Pharm Group with OCI Group hits a major speed bump as the two sons of Hanmi's founder and other candidates recommended by them secture board seats. But it remains to be seen how the Lim brothers will fulfil their ambitious promises.