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


In Brief: Angeion

This article was originally published in The Gray Sheet

Executive Summary

Angeion: Company gains investigational device exemption for clinical studies of its Model 2020 and 2022 implantable cardioverter defibrillators at 35 centers in the U.S. and plans to commence U.S. trials "in a few weeks," company Chairman and CEO Whitney McFarlin reports at a Feb. 5 session of the Piper Jaffray medical device conference in New York City. The 2020, with a weight of 89 grams and volume of 47 cc, is 25% smaller than the firm's 110 gram, 60 cc Sentinel series ICD, for which a June 1997 premarket approval application is pending at FDA ("The Gray Sheet" June 23, In Brief). The 2020 family and Sentinel feature small cap, Tuned biphasic waveform and the ASEC II dual battery system. The 2020 family also offers 60 minutes of electrogram storage. The 2022 model is specifically intended as a replacement device compatible with other manufacturers' lead systems. The devices will be marketed in the U.S. through Angellan Medical Systems' 100-person direct sales force. Angellan is a 50/50 joint venture established by Angeion and Synthelabo's Ela Medical unit. McFarlin also tells investors that Angeion is developing a model 2030 single chamber ICD and a 2100 dual-chamber ICD, for which clinical trials will begin in 1998 and 1999, respectively...

You may also be interested in...

EWG Study Suggests More Than One In 10 Talc-Based Cosmetics Contain Asbestos

The Environmental Working Group and Scientific Analytical Institute say inadequate testing of talc-containing personal-care products is to blame for findings of asbestos in cosmetics, including three of 21 powder-based cosmetics SAI analyzed at EWG’s request. They continue to push for updated testing standards that include electron microscopy as a core component.

Atlas Biomed Unlocking Japan’s OTC Market With Direct-To-Consumer DNA And Microbiome Tests

Can Atlas Biomed unlock Japan's self-care market with its direct-to-consumer DNA and microbiome tests? HBW Insight catches up with the company's co-founder and CEO to discuss this and also how Atlas has been driving its European expansion plans despite coronavirus. 

Hair Supplement Linked To Cases Of Severe Hepatitis In France

France's ANSES warns women using oral contraceptives not to use a supplement marketed by UK firm Hairburst after linking the product's consumption to two cases of severe acute hepatitis.




Ask The Analyst

Ask the Analyst is free for subscribers.  Submit your question and one of our analysts will be in touch.

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