Center Pivot Articles & Analysis
8 news found
The FDA marketing clearance is based on the results of a multi-center, prospective, randomized, double-blind, placebo-controlled clinical study. ...
Rapid Medical, a leading developer of advanced neurovascular devices, announced today the enrollment of the first patient in the DISTALS Study. The trial is the first-ever FDA investigational device exemption (IDE) trial to examine the safety and effectiveness of mechanical thrombectomy in distal stroke. “Enrolling the first patient in this landmark study is an important milestone for ...
” The prospective, single-blinded, multi-center, randomized, non-inferiority pivotal IDE study will evaluate the safety and efficacy of P-15L Bone Graft compared to the use of an autologous bone graft when applied in TLIF surgery. ...
” P-15L Bone Graft is currently being studied in the U.S. in the ASPIRE study, a prospective, single-blinded, multi-center, randomized, non-inferiority pivotal IDE study to evaluate the safety and efficacy of P-15L Bone Graft compared to use of an autologous bone graft when applied in TLIF surgery. ...
Cerapedics Inc., an ortho-biologics company dedicated to enhancing the science of bone repair, announced today the completion of enrollment of the ASPIRE study, a pivotal U.S. Food and Drug Administration (FDA) Investigational Device Exemption (IDE) study, to evaluate the safety and efficacy of P-15L Bone Graft for use in transforaminal lumbar interbody fusion (TLIF) surgery in ...
BOSTON & HYDERABAD, India--( )-- GI Dynamics Inc., a medical device company that isBUSINESS WIRE developing the EndoBarrier® System for patients diagnosed with type 2 diabetes and obesity, is pleased to announce that it has received regulatory approval to begin enrollment in the I-STEP clinical trial in India. I-STEP is a multi-center, randomized, ...
(TSX-V:PINK)(OTC:PYNKF) (FSE:4PC) (“Perimeter” or the “Company”), a medical technology company driven to transform cancer surgery with ultra-high-resolution, real-time, advanced imaging tools to address high unmet medical needs, announced the initiation of a multi-center, randomized, two-arm pivotal clinical trial to evaluate its Perimeter ...
“We are excited to have started enrollment in the pivotal STEM trial,” stated Dr. David Fiorella, (Stony Brook University Medical Center) Co-Primary Investigator of the STEM trial. ...