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

Oceana Therapeutics' Solesta

This article was originally published in The Gray Sheet

Executive Summary

Injectable treatment for fecal incontinence will be submitted for PMA approval in the first quarter of 2010, according to Oceana Therapeutics. The New Jersey firm acquired global marketing rights to Solesta from Swedish developer Q-Med in June. Solesta is a biocompatible substance composed of stabilized hyaluronic acid, including dextranomer. A 200-patient, randomized pivotal study of the minimally invasive device, with 12-month follow-up, "succeeded in meeting both primary endpoints," the firms announced Dec. 7

You may also be interested in...



Regulatory News In Brief

Expanded indications for gastric banding?: FDA's Gastroenterology and Urology Devices advisory panel will meet Dec. 3 to discuss whether the agency should approve expanded indications for Allergan's Lap-Band adjustable gastric banding system. The firm is seeking approval for use in slightly less obese patients, with a body mass index of at least 35 or a BMI of at least 30 if the individual has one or more obesity-related health condition. Currently, the device is labeled for adults with BMIs of 40 or more, or greater than 35 if the patient has a comorbidity. On Dec. 2, the panel will discuss Oceana Therapeutics' PMA for its Solesta fecal incontinence treatment for patients who have failed conservative therapy. The firm's 200-patient pivotal study for the hyaluronic acid-based product met its primary endpoints (1"The Gray Sheet" Dec. 14, 2009)

Chloroquine ‘Approval’ For COVID-19 And The US FDA’s New Reality

Asking whether FDA’s decision to allow emergency use of two old anti-malarial drugs was ‘political’ misses the point. The issue already was political, and FDA’s action may well be the best way to keep some measure of federal control on supplies of a drug with important other uses.

Biopharma, Payers Seek National Guidelines For Prescribing Potential COVID-19 Drugs

Guidelines for health care providers could help prevent shortages as demand for possible treatments surge, groups say. Stakeholders also argue “Buy America” executive order would hamper drug access.

Topics

UsernamePublicRestriction

Register

MT028278

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