Ethicon Endo-Surgery's division Sedasys has received premarket approval (PMA) from the US Food and Drug Administration (FDA) for the first computer-assisted personalized sedation (CAPS) solution, Sedasys System.
The system is used for the intravenous administration of 1% (10 mg/mL) propofol injectable emulsion for the initiation and maintenance of minimal-to-moderate sedation in the American Society of Anesthesiologists (ASA) physical status I and II patients greater than or equal to 18 years old undergoing colonoscopy and esophagogastroduodenoscopy (EGD) procedures.
The Sedasys System is expected to minimise risks associated with oversedation, facilitate faster patient recovery and increase physician satisfaction.
Charlottesville Medical Research, US, medical director and principal investigator Daniel Pambianco said the Sedasys System will address the growing preference for propofol (brand name Diprivan) sedation in gastroenterology by more closely matching the skill level of the sedation delivery team with the actual requirements of less complex cases.
"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," Pambianco added.
The approval was based on the clinical data, which demonstrated that patients sedated with the Sedasys System recovered faster than the control group, with 99% recovered from the effects of sedation within 10 minutes.
Sedasys is a trademark of Ethicon Endo-Surgery, which is part of the Johnson & Johnson Family of Companies while Diprivan is a registered trademark of the AstraZeneca group of companies.
