Navigation Links
FDA Advisory Panel Recommends Approval of the SEDASYS(R) System
Date:5/28/2009

Panel Votes in Favor of Use by Physician/Nurse Teams to Deliver Minimal-to-Moderate Propofol Sedation

CINCINNATI, May 28 /PRNewswire/ -- Ethicon Endo-Surgery today announced that the Anesthesiology and Respiratory Therapy Devices Advisory Committee of the U.S. Food and Drug Administration (FDA) voted in favor of approval of the SEDASYS(R) System for use by physician/nurse teams to administer minimal-to-moderate propofol sedation during screening and diagnostic procedures for colorectal cancer (colonoscopy) and the upper gastrointestinal tract (EGD). The SEDASYS(R) System, the first computer-assisted personalized sedation (CAPS) system, integrates drug delivery and patient monitoring to enable propofol sedation personalized to each patient's needs.

The Anesthesiology and Respiratory Therapy Devices Advisory Committee voted 8 to 2 in favor of approval. Conditions of approval recommended by the Panel included that the SEDASYS(R) System only be used in adult patients age 70 and under, a comprehensive training program, definition of the sedation delivery team and a post-approval study. The final decision regarding approval of the device is made by the FDA.

"There is strong clinical support that the SEDASYS(R) System reduces the risk of over-sedation, which may help make sedation more predictable and reliable for physician/nurse teams," said Kenneth Sumner, Ph.D., Vice President, Clinical and Regulatory Affairs, Ethicon Endo-Surgery, Inc. "We look forward to continuing discussions with the FDA during the regulatory review process."

The Advisory Committee reviewed results from a recent pivotal trial, which were included in the company's Pre-Market Approval (PMA) application for the SEDASYS(R) System. In the study, patients who received sedation with the SEDASYS(R) System experienced fewer and less significant oxygen desaturation events, a clinical sign of over-sedation, than patients sedated with the current standard of care drugs -- benzodiazepines and opioids.

The SEDASYS(R) System automatically detects and responds to signs of over-sedation (oxygen desaturation and low respiratory rate/apnea), guided by continual monitoring and recording of critical patient vital signs, including oxygen saturation, respiratory rate, heart rate, blood pressure, end-tidal carbon dioxide and patient responsiveness.

Propofol (also known as DIPRIVAN(R)) is considered by physicians to be a preferred sedative due to its rapid onset and quick, clear-headed recovery, which enables patients to promptly return to normal activities following a colonoscopy or EGD procedure. Current propofol labeling states only persons trained in the administration of general anesthesia should administer the drug. In the majority of practice settings, gastroenterologists do not have broad access to anesthesiologists.

About the SEDASYS(R) System

The SEDASYS(R) System is the first computer-assisted personalized sedation (CAPS) system designed for physician/nurse teams to provide minimal-to-moderate sedation levels with propofol. By integrating drug delivery and patient monitoring, the SEDASYS(R) System enables physician/nurse teams to deliver personalized sedation. It automatically detects and responds to signs of over-sedation (oxygen desaturation and low respiratory rate/apnea) by stopping or reducing delivery of propofol, increasing oxygen delivery and automatically instructing patients to take a deep breath. The device is currently an investigational device limited by U.S. law to investigational use only.

About Ethicon Endo-Surgery

Ethicon Endo-Surgery, a Johnson & Johnson company, develops and markets advanced medical devices for minimally invasive and open surgical procedures, focusing on procedure-enabling devices for the interventional diagnosis and treatment of conditions in general and bariatric surgery, as well as gastrointestinal health, gynecology and surgical oncology. More information can be found at www.ethiconendo.com.

(C)2009 Ethicon Endo-Surgery

SEDASYS(R) is a trademark of Ethicon Endo-Surgery.

DIPRIVAN(R) is a registered trademark of the AstraZeneca group of companies.

    CONTACTS:  Media:                  Investor Relations:
               Kelly Leadem            Stan Panasewicz
               Ethicon Endo-Surgery    Johnson & Johnson
               513-337-1006            732-524-2524
               973-713-6927

               Wendy Dougherty         Louise Mehrotra
               Ethicon Endo-Surgery    Johnson & Johnson
               513-337-8281            732-524-6491
               513- 293-0254


'/>"/>
SOURCE Ethicon Endo-Surgery
Copyright©2009 PR Newswire.
All rights reserved

Related medicine technology :

1. Update on FDA Advisory Committee Meeting on Liraglutide for the Treatment of Type 2 Diabetes
2. FDA Advisory Committee Recommends Approval of Multaq(R) (dronedarone)
3. Savient Announces FDAs Advisory Panel to Review Pegloticase for Treatment-Failure Gout Patients
4. AstraZeneca Responds to FDA Joint Advisory Committees Recommendation on SYMBICORT(R)
5. Arthritis Advisory Committee Recommends FDA Approval of Febuxostat for the Treatment of Hyperuricemia in Patients With Gout
6. New Jersey American Water Lifts Precautionary Boil Water Advisory For Middlesex, Somerset and Union Counties
7. Arpida Comments on FDAs Anti-infective Drugs Advisory Committee Outcome
8. Arpida Announces Review of Iclaprim NDA by FDA Advisory Committee in November 2008
9. News Media Advisory: Worlds Leading Surgical Oncologists to Gather at McLaren Regional Medical Center to Present Latest Work on Breast, Gastrointestinal Cancer Treatments
10. FDA Advisory Committee Unanimously Recommends Approval of Ustekinumab for Treatment of Moderate to Severe Plaque Psoriasis
11. UBC Forms European Advisory Board to Enhance Data Quality of CNS Trials
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:6/24/2016)... DUBLIN , June 24, 2016 ... and Markets has announced the addition of the ... their offering. ... products and provides an updated review, including its applications ... covering the total market, which includes three main industries: ...
(Date:6/24/2016)... 2016 Dehaier Medical Systems Ltd. (NASDAQ: ... markets and sells medical devices and wearable sleep respiratory ... strategic cooperation agreement with Hongyuan Supply Chain Management Co., ... June 20, 2016, to develop Dehaier,s new Internet medical ... Dehaier will leverage Hongyuan Supply Chain,s sales platform to ...
(Date:6/24/2016)... June 24, 2016 According to ... Type (Standard Pen Needles, Safety Pen Needles), Needle Length ... Growth Hormone), Mode of Purchase (Retail, Non-Retail) - Trends ... report studies the market for the forecast period of ... USD 2.81 Billion by 2021 from USD 1.65 Billion ...
Breaking Medicine Technology:
(Date:6/26/2016)... ... June 26, 2016 , ... Brent Kasmer, a legally blind and certified personal trainer is helping ... fitness app. The fitness app plans to fix the two major problems leading the fitness ... size fits all type program , They don’t eliminate all the reasons people ...
(Date:6/25/2016)... ... ... temporary closing of Bruton Memorial Library on June 21 due to a possible lice infestation, ... aspect of head lice: the parasite’s ability to live away from a human host, and ... necessary one in the event that lice have simply gotten out of control. , As ...
(Date:6/25/2016)... ... 25, 2016 , ... Dr. Calvin Johnson has dedicated his ... implemented orthobiologic procedures as a method for treating his patients. The procedure is ... to perform the treatment. Orthobiologics are substances that orthopaedic surgeons use to help ...
(Date:6/24/2016)... ... June 24, 2016 , ... Those who have experienced traumatic events may suffer ... unhealthy avenues, such as drug or alcohol abuse, as a coping mechanism. To avoid ... healthy coping following a traumatic event. , Trauma sufferers tend to feel a range ...
(Date:6/24/2016)... MIAMI, Fla. (PRWEB) , ... June 24, 2016 , ... ... Florida Trend magazine’s 2016 Legal Elite. The attorneys chosen by their peers for this ... of Florida. , Seven Greenberg Traurig Shareholders received special honors as members of this ...
Breaking Medicine News(10 mins):