Procedural sedation and analgesia

DGAP-News: PAION REPORTS POSITIVE REMIMAZOLAM TOPLINE DATA IN EU PHASE III TRIAL IN GENERAL ANESTHESIA

Thursday, November 19, 2020 - 10:07pm

- Key secondary endpoint met: remimazolam demonstrated superior hemodynamic stability compared to propofol

Key Points: 
  • - Key secondary endpoint met: remimazolam demonstrated superior hemodynamic stability compared to propofol
    - EU Phase III program completed; data to serve as basis for MAA submission in general anesthesia
    Aachen (Germany), 19 November 2020 - The Specialty Pharma Company PAION AG (ISIN DE000A0B65S3; Frankfurt Stock Exchange Prime Standard: PA8) today announces positive topline data from the pivotal remimazolam EU Phase III trial in general anesthesia.
  • Assuming approval in procedural sedation, PAION plans to submit an extension of the marketing authorization for remimazolam for general anesthesia.
  • In addition to procedural sedation and general anesthesia, based on positive Phase II study results, ICU sedation is another possible indication for remimazolam.
  • In Europe, PAION is seeking approval of remimazolam for general anesthesia and for procedural sedation.

DGAP-News: PAION AG REPORTS FINANCIAL RESULTS FOR THE FIRST HALF-YEAR 2020

Wednesday, August 12, 2020 - 7:01am

In the U.S., the FDA (U.S. Food & Drug Administration) granted market approval of BYFAVOTM (remimazolam) for procedural sedation in July 2020.

Key Points: 
  • In the U.S., the FDA (U.S. Food & Drug Administration) granted market approval of BYFAVOTM (remimazolam) for procedural sedation in July 2020.
  • In July 2020, after market approval of BYFAVOTM, PAION, Cosmo and Acacia agreed to assign the BYFAVOTM license agreement signed in 2016 between Cosmo and PAION to Acacia.
  • In Europe, PAION is seeking approval for remimazolam in procedural sedation and in general anesthesia.
  • Procedural sedation: PAION submitted a Marketing Authorization Application (MAA) for procedural sedation to the European Medicines Agency (EMA) in November 2019.

New Blinded Observational Study Shows Greater Depth of Patient Sedation Than Intended During Procedural Colonoscopy

Monday, August 3, 2020 - 1:00pm

Anesthesiologists and endoscopists may utilize processed EEG to recognize their institutional practice patterns of procedural sedation with propofol and improve upon it.

Key Points: 
  • Anesthesiologists and endoscopists may utilize processed EEG to recognize their institutional practice patterns of procedural sedation with propofol and improve upon it.
  • Based on the study results, the researchers concluded, The depth of sedation achieved with anesthesia administered propofol for colonoscopy spans a continuum.
  • Although providers planned for moderate to deep sedation, processed EEG in this study revealed a substantially greater depth consistent with general anesthesia and even burst suppression.
  • Further research is required to establish the impact on patient outcomes of anesthetic practices resulting in intraprocedural burst suppression.

DGAP-News: PAION ANNOUNCES U.S. FDA APPROVAL OF REMIMAZOLAM (BYFAVOTM) FOR THE INDUCTION AND MAINTENANCE OF PROCEDURAL SEDATION

Thursday, July 2, 2020 - 8:01pm

"We are very pleased to announce today the approval of BYFAVOTM in the U.S. for procedural sedation in adult patients," commented Mike Bolinder, Acacia Pharma's CEO.

Key Points: 
  • "We are very pleased to announce today the approval of BYFAVOTM in the U.S. for procedural sedation in adult patients," commented Mike Bolinder, Acacia Pharma's CEO.
  • In addition to procedural sedation and general anesthesia, based on positive Phase II study results, ICU sedation is another possible indication for remimazolam.
  • In China, licensee Yichang Humanwell filed for market approval in procedural sedation in November 2018 and in South Korea, licensee Hana Pharm filed for market approval for remimazolam in general anesthesia in December 2019.
  • In Europe, PAION is seeking approval of remimazolam for general anesthesia and for procedural sedation.

Conformal Medical Announces First Left Atrial Appendage Closures Performed Under Conscious Sedation with its CLAAS Technology at AF Symposium 2020

Wednesday, January 22, 2020 - 1:50pm

NASHUA, N.H., Jan. 22, 2020 (GLOBE NEWSWIRE) -- Conformal Medical, Inc. announced today the presentation of the first left atrial appendage closure (LAAC) cases with its unique CLAAS Technology in patients under conscious sedation without general anesthesia.

Key Points: 
  • NASHUA, N.H., Jan. 22, 2020 (GLOBE NEWSWIRE) -- Conformal Medical, Inc. announced today the presentation of the first left atrial appendage closure (LAAC) cases with its unique CLAAS Technology in patients under conscious sedation without general anesthesia.
  • Petr Neuzil and Vivek Reddy will present ICE-Guided Implantation of the Conformal Left Atrial Appendage Closure Device: First Clinical Report at the AF Symposium meeting in Washington, D.C., January 23-24.
  • These first procedures using the conscious sedation protocol were successfully performed at Homolka Hospital in Prague, Czech Republic.
  • Conformal Medical, Inc. is a medical device company founded in 2016 to develop devices to prevent stroke in patients with atrial fibrillation.

Dentist, Dr. Jacqueline Subka, Relieves Dental Anxiety in Calabasas, CA with Sedation Dentistry

Thursday, August 1, 2019 - 12:40pm

CALABASAS, Calif., August 1, 2019 /PRNewswire-PRWeb/ -- Trusted dentist, Dr. Jacqueline Subka, welcomes those who suffer from dental anxiety in Calabasas, CA to receive custom sedation dentistry treatment at her relaxing and comfortable practice in Thousand Oaks, CA.

Key Points: 
  • CALABASAS, Calif., August 1, 2019 /PRNewswire-PRWeb/ -- Trusted dentist, Dr. Jacqueline Subka, welcomes those who suffer from dental anxiety in Calabasas, CA to receive custom sedation dentistry treatment at her relaxing and comfortable practice in Thousand Oaks, CA.
  • Sedation dentistry uses medications to calm patients who have dental anxiety, enabling them to undergo routine procedures or even combine procedures in order to decrease their number of visits.
  • Dr. Subka offers four types of sedation dentistry: oral sedation, nitrous oxide, IV conscious sedation and local anesthetic.
  • Dr. Jacqueline Subka is a general dentist offering personalized dental care for patients in Thousand Oaks, CA since 1999.

Recommendations for Procedural Sedation

Thursday, May 10, 2018 - 2:45pm

CHICAGO, May 10, 2018 /PRNewswire/ -- The Physician-Patient Alliance for Health & Safety (PPAHS) announced its intention to develop a position statement on recommendations for procedural sedation.

Key Points: 
  • CHICAGO, May 10, 2018 /PRNewswire/ -- The Physician-Patient Alliance for Health & Safety (PPAHS) announced its intention to develop a position statement on recommendations for procedural sedation.
  • Michael Wong, JD (Founder and Executive Director, PPAHS) explained that such a position statement on recommendations for procedural sedation would encapsulate guidelines and recommendations from leading medical organizations in Canada and the United States:
    Mr. Wong noted the interest of the PPAHS in procedural sedation, citing recent clinical education podcasts that PPAHS has produced and released:
    " Capnography Monitoring: Yesterday's Luxury, Today's Necessity During Conscious Sedation " which featured an interview with Matt Kurrek, MD, FRCPC (Professor, Department of Anesthesia, University of Toronto) and Richard Merchant, MD, FRCPC (Clinical Professor, University of British Columbia, Department of Anesthesia, Pharmacology & Therapeutics).
  • The CSA guidelines emphasize the need for end tidal CO2 monitoring during conscious sedation.
  • Kurrek and Merchant discuss why capnography monitoring may have been considered yesterday's luxury, but is now a necessity during procedures involving conscious sedation.
    "