Sedana Medical's Sedaconda study post-hoc analysis published in the Journal of Critical Care
Sedana Medical AB (publ) announces the publication of a post-hoc analysis of the company's pivotal Sedaconda study (SED001) in the Journal of Critical Care. The post-hoc analysis that focused on long-term outcomes demonstrated 3.5 more ICU-free days and less additional sedative use for mechanically ventilated intensive care unit (ICU) patients treated with isoflurane as the main sedative in comparison to patients receiving propofol as the main sedative.
The publication, entitled “ICU- and ventilator-free days with isoflurane or propofol as a primary sedative - A post-hoc analysis of a randomized controlled trial” showed that patients from the Sedaconda study who received isoflurane as the main sedative during the 30 days from enrolment had 3.5 more days alive and outside the ICU than patients treated with propofol as the main sedative. Ventilator-free days were numerically in favour of isoflurane but the difference was not statistically significant. Isoflurane-treated patients had less need for additional sedatives in comparison to those receiving propofol. Additionally, renal replacement therapy was started in a greater proportion of patients in the propofol group compared to the isoflurane group.
In 2022, these results contributed to the recommendation of inhaled sedation via Sedana Medical’s proprietary device Sedaconda ACD as a cost saving option by the National Institute for Health and Care Excellence (NICE) in the UK.
“The publication of this post-hoc analysis confirms several key benefits of inhaled sedation, most notably shorter ICU stay and less need for additional sedatives”, says Peter Sackey, Chief Medical Officer of Sedana Medical. “Since the NICE recommendation was based on these data, it is a strength that the results have now been peer-reviewed and published. The results in favour of isoflurane are very significant for patients, clinicians and decision-makers in ICUs worldwide. Reducing the need for additional sedatives means patients have less risk of developing complications due to drug-drug interactions and dose-dependent adverse events. A shorter stay in the ICU implies earlier mobilization and rehabilitation of the critically ill patient and a significant reduction of the associated healthcare cost.”
“These days, many of our hospital customers are facing economic pressures and are struggling with staff shortages. Thanks to inhaled sedation with our Sedaconda products, patients can be discharged from the ICU several days earlier on average, which leads to cost savings and better utilization of scarce ICU resources”, says Johannes Doll, President and CEO of Sedana Medical.
The positive outcomes in this new publication add to those from the main Sedaconda study (SED001), which formed the basis for Sedana Medical's European market approval. The Sedaconda study included 301 mechanically ventilated patients in need of sedation and demonstrated that Sedaconda (isoflurane) administered via the Sedaconda ACD reduced the need of opioids, enabled a faster and more predictable awakening and facilitated spontaneous breathing to a greater extent than intravenous propofol.
For additional information, please contact:
Johannes Doll, CEO, +46 (0)76 303 66 66
Johan Spetz, CFO, +46 (0)730 36 37 89
[email protected]
About Sedana Medical
Sedana Medical AB (publ) is a pioneer medtech and pharmaceutical company focused on inhaled sedation to improve the patient’s life during and beyond sedation. Through the combined strengths of the medical device Sedaconda ACD and the pharmaceutical Sedaconda (isoflurane), Sedana Medical provides inhaled sedation for mechanically ventilated patients in intensive care.
Sedana Medical has direct sales in Benelux, France, Germany, Great Britain, the Nordics, and Spain. In other parts of Europe as well as in Asia, Australia, Canada, and South- and Central America, the company works with external distributors.
Sedana Medical was founded in 2005, is listed on Nasdaq Stockholm (SEDANA) and headquartered in Stockholm, Sweden.