FDA Grants Premarket Approval (PMA) For The SEDASYS® System For Healthy Patients Undergoing Sedation During Routine Colonoscopy And EGD Procedures
Reduces risks associated with oversedation, facilitates faster patient recovery and increases physician satisfaction
Cincinnati, Ohio, May 3, 2013 – Sedasys, a Division of Ethicon Endo-Surgery, Inc. (Ethicon), today announced that the U.S. Food and Drug Administration (FDA) has granted PMA approval for the SEDASYS® System, the first computer-assisted personalized sedation (CAPS) system.
The SEDASYS System is indicated for the intravenous administration of 1% (10 mg/mL) propofol injectable emulsion for the initiation and maintenance of minimal- to-moderate sedation, as defined by the American Society of Anesthesiologists (ASA) Continuum of Depth of Sedation, in ASA physical status I and II patients ≥18 years old undergoing colonoscopy and esophagogastroduodenoscopy (EGD) procedures.
The SEDASYS System has the potential to redefine sedation delivery by enabling physician-led teams to administer minimal-to-moderate propofol sedation, personalized to the needs of each patient, by precisely integrating drug delivery and comprehensive patient monitoring. The company estimates that 15 million patients in the U.S. are candidates for these procedures.
In introducing this first-of-its-kind technology, the company will offer the SEDASYS System to facilities where an anesthesia professional is immediately available for assistance or consultation. In addition to receiving device-specific training, the member of the physician-led team who is administering sedation must have training in the management of cardiorespiratory effects of propofol. The SEDASYS System is expected to be introduced on a limited basis beginning in 2014. The company will collaborate with the gastroenterology, anesthesiology and nursing communities to successfully integrate the SEDASYS System, and conduct two post-approval studies to monitor the use of the technology in actual clinical practice.
"The SEDASYS System will address the growing preference for propofol sedation in gastroenterology by more closely matching the skill level of the sedation delivery team with the actual requirements of less complex cases," said Daniel Pambianco*, M.D., Medical Director, Charlottesville Medical Research, Charlottesville, Va., and Principal Investigator. "The technology will empower health care facilities to more effectively use their limited resources to deliver greater value in the increasingly resource-constrained U.S. health care environment."
Dr. Pambianco added, "Anesthesiologists and gastroenterologists were key participants in the development of the SEDASYS System, and we believe the technology has the potential to improve the experiences of both the clinical team and the patient."
Data included in the company's PMA application demonstrated that the System reduces the risks associated with over sedation because patients who received sedation with the SEDASYS System experienced fewer and less significant oxygen desaturation events than patients in the control group who received traditional sedation with benzodiazapines and opioids. The data also demonstrated that patients sedated with the SEDASYS System recovered faster than the control group, with 99 percent recovered from the effects of sedation within 10 minutes, and that patients were highly satisfied. In addition, physicians were significantly more satisfied with administration of sedation they provided to patients in the SEDASYS System group compared to sedation provided to patients in the control group.
Propofol (brand name DIPRIVAN®) is considered by physicians to be a preferred sedative because it provides a rapid onset and quick, clear-headed recovery for patients, which enables them to return promptly to activities of daily living.
The SEDASYS System will be marketed by Sedasys, a Division of Ethicon Endo-Surgery, Inc. (Ethicon), which is part of the Johnson & Johnson Family of Companies. The Sedasys division is committed to redefining the practice of sedation by developing and facilitating access to innovative solutions that enable health care systems to deliver greater value.
* Dr. Pambianco is a paid consultant to the company.
SEDASYS® is a trademark of Ethicon Endo-Surgery, Inc.
DIPRIVAN® is a registered trademark of the AstraZeneca group of companies.
(This press release contains "forward-looking statements" as defined in the Private Securities Litigation Reform Act of 1995. The reader is cautioned not to rely on these forward-looking statements. These statements are based on current expectations of future events. If underlying assumptions prove inaccurate or unknown risks or uncertainties materialize, actual results could vary materially from the expectations and projections of Ethicon Endo-Surgery, Inc. and/or Johnson & Johnson. Risks and uncertainties include, but are not limited to, general industry conditions and competition; economic factors, such as interest rate and currency exchange rate fluctuations; technological advances, new products and patents attained by competitors; challenges inherent in new product development, including obtaining regulatory approvals; challenges to patents; changes in behavior and spending patterns or financial distress of purchasers of health care products and services; changes to governmental laws and regulations and domestic and foreign health care reforms; trends toward health care cost containment; increased scrutiny of the health care industry by government agencies; and manufacturing difficulties or delays. A further list and description of these risks, uncertainties and other factors can be found in Exhibit 99 of Johnson & Johnson's Annual Report on Form 10-K for the fiscal year ended December 30, 2012. Copies of this Form 10-K, as well as subsequent filings, are available online at www.sec.gov, www.jnj.comor on request from Johnson & Johnson. Neither Ethicon Endo-Surgery, Inc. nor Johnson & Johnson undertake to update any forward-looking statements as a result of new information or future events or developments.)