Kensey Nash
This article was originally published in The Gray Sheet
Executive Summary
FDA approves an investigational device exemption for a feasibility study of the firm's new version of the TriActiv embolic protection system for carotid stenting procedures, Kensey announces Nov. 3. The study is scheduled to begin this month. The Exton, Penn. company has already commenced a similar study in Europe in pursuit of a CE mark, which it hopes to obtain in 2006. The TriActiv system was 510(k)-cleared in March for embolic protection during saphenous vein graft procedures (1"The Gray Sheet" March 28, 2005, In Brief)...
You may also be interested in...
TriActiv approval
Kensey Nash's 12-rep direct U.S. sales force will market the embolic protection system for saphenous vein graft (SVG) procedures following 510(k) clearance, announced March 24. TriActiv will compete with Boston Scientific's FilterWire and Medtronic's GuardWire in the estimated $100 mil.-$120 mil. marketfor SVG embolic protection. Kensey Nash is eyeing further indications and future-generation systems to expand the market (1"The Gray Sheet" March 21, 2005, p. 27)...
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.