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

Eclipse Surgical Technologies

This article was originally published in The Gray Sheet

Executive Summary

Data are submitted to FDA in support of market clearance for catheter-based percutaneous transluminal myocardial revascularization (PTMR) by interventional cardiologists. The company received FDA approval for open-chest transmyocardial revascularization using the Eclipse TMR 2000 solid-state laser system in February 1999 (1"The Gray Sheet" Feb. 15, 1999, p. 3). The PTMR submission includes 12-month data from a randomized, controlled multi-center study comparing PTMR to drug therapy in patients with severe angina and no other procedural options

You may also be interested in...



Eclipse Surgical TMR Laser Shipments Commence Following FDA Approval

Shipments of Eclipse Surgical Technologies' Eclipse 2000 transmyocardial revascularization laser system began "immediately" following FDA approval, announced Feb. 11, at a price of $295,000 each, according to the firm.

Finance Watch: Silverback, Kinnate, Sigilon Launch December’s First IPOs

Public Company Edition: Lixte’s small uplisting was the only biopharma initial public offering in the US during Thanksgiving week, but IPOs are ramping up again. Also, LifeSci launched its second SPAC and in follow-on offerings Reata brought in $281m and Intellia grossed $175m.

BioCryst’s Oral Option To Take On Injectables In HAE Prophylaxis Market

Orladeyo is the first oral prophylactic approved in the US for hereditary angioedema, with Japan and EU approvals expected to follow. Pricing of $485,000 a year undercuts segment leader.

UsernamePublicRestriction

Register

ID1132679

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

Cancel