Medtech Insight is part of Pharma Intelligence UK Limited

This site is operated by Pharma Intelligence UK Limited, a company registered in England and Wales with company number 13787459 whose registered office is 5 Howick Place, London SW1P 1WG. The Pharma Intelligence group is owned by Caerus Topco S.à r.l. and all copyright resides with the group.

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

SurModics Resumes TRANSCEND Trial Of SurVeil Drug-Coated Balloon

Executive Summary

SurModics suspended the trial with their SurVeil drug-coated balloon in March after the US FDA sent a letter to physicians alerting them to possible safety problem with paclitaxel-coated devices. The company has updated the patient consent form and established a new patient follow-up program for the trial.

You may also be interested in...



FDA Panel To Address Paclitaxel Safety Concerns

The US FDA will soon hold a meeting to discuss paclitaxel-coated devices to treat peripheral arterial disease. The drug-eluting stents and balloons have been subject to increased scrutiny since a meta-analysis found they were linked to a higher patient mortality rate.

SurModics Recruits Abbott To Commercialize SurVeil Drug-Coated Balloon

Abbott will pay SurModics $25m upfront and up to $67m in milestones for the exclusive right to commercialization SurVeil worldwide.

Acclarent Expects TruDi Shaver Blade To Prevent Repeat ENT Surgeries

The FDA recently cleared the TruDi Shaver Blade, an electromagnetically navigated blade for the incision and removal of soft and hard tissue or bone in ear, nose, throat, and maxillofacial surgery, as well as head and neck and skull-base surgery.

Topics

Related Companies

Latest News
See All
UsernamePublicRestriction

Register

MT124997

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