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

Medstone's STS Lithotriptor

This article was originally published in The Gray Sheet

Executive Summary

Firm suffers setback in long-standing bid to commercialize the first lithotriptor for fragmenting biliary stones with FDA's decision not to approve the firm's September 1997 combination premarket approval application/supplemental new drug application. In April, FDA's Gastroenterology and Urology Devices Panel had recommended that FDA approve the device, which in combination with Novartis' Actigall (ursodiol) anti-gallstone drug is intended to fragment and clear the function of the gall bladder of symptomatic, radiolucent, non-calcified stones 4-20 mm in diameter. The device already is approved for fragmenting kidney stones
Advertisement
Advertisement
UsernamePublicRestriction

Register

MT010473

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