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: Research Medical

This article was originally published in The Gray Sheet

Executive Summary

Research Medical: Plans to unveil its disposable beating heart minimally invasive cardiac surgery product line at the February 1997 Society of Thoracic Surgeons Meeting in San Deigo. The line includes the Anastaflo intravascular shunt for insertion into both ends of the severed coronary artery to prevent excess blood loss and the Visuflo humidified air blower with light source for lighting and removal of unwanted blood, both of which have been cleared by FDA. In addition, a "heart elevator" to minimize movement during bypass, a "stabilizing suction wand" to immobilize the section of heart operated on, and a femoral-to-arterial shunt to provide femoral artery blood flow to regions below the grafting site are expected to be 510(k) cleared in early 1997. The Midvale, Utah-based firm says Anastaflo and Visuflo will be commercially available by the end of the current quarter, with the other three devices expected to reach the market in June 1997...

You may also be interested in...

Gene Therapy Approvals By US FDA Could Double In 2020

CBER is starting the year with four novel gene and cell therapy applications under review and rolling submissions underway for more.

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.




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