Medtech Insight is part of Informa PLC

This site is operated by a business or businesses owned by Informa PLC and all copyright resides with them. Informa PLC’s registered office is 5 Howick Place, London SW1P 1WG. Registered in England and Wales. Number 8860726.

This copy is for your personal, non-commercial use. For high-quality copies or electronic reprints for distribution to colleagues or customers, please call +44 (0) 20 3377 3183

Printed By

UsernamePublicRestriction
UsernamePublicRestriction

Guidant and Medtronic get implantable cardioverter defibrillator (ICD) approvals

This article was originally published in Clinica

Executive Summary

The US FDA has approved ICDs manufactured by Medtronic and Guidant for pectoral implantation. Guidant has received marketing approval for its 68 cc Ventak Mini Hot Can and 59 cc Mini II ICDs. Both devices use the Endotak Triad three-electrode lead system. The Mini Hot Can is 29% smaller than Medtronic's 83 cc Jewel - which was the first ICD to receive pectoral approval in the US in March 1995 (see Clinica No 647, p 19).

You may also be interested in...



Long Hot Summer For Novel Drug Reviews Forecast At US FDA

Submission surge in late 2019 means a spike in late summer 2020 user fee goals, including 16 novel agents in August alone.

Keeping Track: Approvals For Tazverik And Tepezza, Priority Reviews For Belantamab Mafodotin And Lynparza

The latest drug development news and highlights from our US FDA Performance Tracker.

Epizyme’s Tazverik Gets To Market In Rare Sarcoma, Paving Way To Bigger Indications

Accelerated approval in epithelial sarcoma may de-risk the firm’s goals for approval of Tazverik in follicular lymphoma and other larger indications.

Topics

UsernamePublicRestriction

Register

MT088066

Ask The Analyst

Please Note: You can also Click below Link for Ask the Analyst
Ask The Analyst

Your question has been successfully sent to the email address below and we will get back as soon as possible. my@email.address.

All fields are required.

Please make sure all fields are completed.

Please make sure you have filled out all fields

Please make sure you have filled out all fields

Please enter a valid e-mail address

Please enter a valid Phone Number

Ask your question to our analysts

Cancel