Health

Occlutech granted important conditional FDA approval for PFO Study (OCCLUFLEX) in the U.S.

Occlutech Holding AG (“Occlutech”), one of the world´s leading providers of minimally invasive structural heart disease devices, announces the conditional U.S. Food and Drug Administration (“FDA”) approval of its Investigational Device Exemption (“IDE”) application to conduct a pivotal study, OCCLUFLEX, comparing Patent Foramen Ovale (“PFO”) closure by Occlutech’s Flex II PFO Occluder to the…

thaipr.net

17 ส.ค. 64

MedAlliance announces Completion of Enrolment in PRISTINE Clinical Trial with SELUTION SLR™ Sirolimus Drug Eluting Balloon

MedAlliance has announced completion of patient enrolment in the PRISTINE clinical trial with SELUTION SLR™ 018 DEB (drug-eluting balloon) for the treatment of patients with Below-the-Knee (BTK) disease. SELUTION SLR is the first DEB to be awarded “Breakthrough Device Designation” by the FDA. PRISTINE is a Prospective Registry to Investigate the Safety and efficacy of Treatment with SELUTION SLR Sirolimus […]

thaipr.net

13 ส.ค. 64

Novavax Announces COVID-19 Vaccine Booster Data Demonstrating Four-Fold Increase in Neutralizing Antibody Levels Versus Peak Responses After Primary Vaccination

Single booster dose at 6 months of NVX-CoV2373 increased wild-type neutralizing antibodies more than 4-fold versus primary vaccination series Six-fold increase in cross-reactive functional antibodies to Delta variant compared to primary vaccination series Analysis of sera from primary vaccination series also showed cross-reactive functional antibodies to Alpha, Beta and Delta variants, all of which increased […]

thaipr.net

6 ส.ค. 64
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