Tele: 561.316.3330
Breaking Medical Device News

Thursday, October 21, 2021


HomeiSchemaViewRAPID™ Imaging Platform Chosen for Patient Selection in TIMELESS Trial

RAPID™ Imaging Platform Chosen for Patient Selection in TIMELESS Trial

RAPID Continues to be a Validated Imaging Platform for Stroke Research. Now Used in a New Study to Evaluate the Efficacy and Safety of Tenecteplase Compared With Placebo in Patients with Acute Ischemic Stroke

iSchemaView today announced that the company’s RAPID imaging platform has been chosen for use in determining subject eligibility for the “Thrombolysis in imaging eligible late window patients (4.5-24 hours) to evaluate the efficacy and safety of tenecteplase,” TIMELESS trial, which will evaluate the efficacy and safety of tenecteplase compared with placebo in patients with late window acute ischemic stroke (AIS). Genentech, a member of the Roche Group, sponsored the study.

Stroke is the third leading cause of death and primary cause of long-term disability in the United States. Acute ischemic strokes (AIS) account for 87 percent of all strokes. An ischemic stroke occurs when an obstruction, like a blood clot, blocks blood flow to the brain.

The TIMELESS trial is designed to evaluate whether tenecteplase is safe and effective for use in AIS when administered between 4.5 and 24 hours after stroke onset.

“Advanced imaging with RAPID was instrumental in changing the AHA guidelines for thrombectomy (mechanical reperfusion) and has the potential to be equally impactful for thrombolysis (chemical reperfusion),” said Mikayel Grigoryan, M.D., Medical Director of Neurointervention at Adventist Health Glendale Comprehensive Stroke Center.

Unique in the comprehensive depth and range of its clinical validation, RAPID is now also the imaging standard in stroke research. iSchemaView’s imaging solution now has a research footprint across more than 300 stroke centers, more than 10 large-scale international clinical trials, and is being used clinically in over 800 hospitals worldwide. RAPID has been shown to aid in the selection of patients in early and late-window stroke trials, including SWIFT PRIME, EXTEND IA, DAWN, DEFUSE 3 and EXTEND, and has been granted FDA clearance for selection of patients for both early and late window thrombectomy.

“The choice of iSchemaView for the TIMELESS study makes it clear: RAPID is the de facto standard for clinical trials in stroke,” said Carolina Maier, PhD, Vice President of Research at iSchemaView. “RAPID is the only imaging technology for stroke that has been clinically validated, which is why it has been used in such a broad range of clinical trials and why it is used in over 1,000 stroke centers worldwide.”

Medical Device News Magazine
Medical Device News Magazine is a division of PTM Healthcare Marketing, Inc. Pauline T. Mayer is the managing editor.

Stay Connected


Don't Miss

Contraline Closes $10.7 Million Series A Financing to Become a Clinical Stage Company

This infusion of capital will support the initiation of a first-in-human trial of ADAM™, the world’s first hydrogel implant designed to provide long-lasting, non-permanent contraception for men.

Adam S. Epstein New CEO of AliMed, Inc.

In his prior role as Chief Commercial Officer, Epstein directed all customer-facing, demand generation and product development activities. Under his new leadership, AliMed will continue to build a robust portfolio of contracted positions with major, national GPO’s, IDN’s, and Distribution partners to drive sales growth.

Tony Collins Appointed CFO of Xenter

“Xenter is building a platform for medical innovations that is transformational. The only way we can achieve our objectives is if we have great leaders like Tony Collins leading our company,” stated Richard J. Linder, Founder, Chairman & CEO of Xenter, Inc. “Tony brings incredible depth and experience to his new role as Chief Financial Officer.

Scott Sexton Appointed President at FIGUR8

"Scott brings to FIGUR8 30 years of workers' compensation, casualty, disability, and commercial health experience, most recently serving as a market leader for CorVel's national carrier practice sales team," said Nan-Wei Gong, CEO, and co-founder of FIGUR8.

Insulet Announces Board of Director Changes with Appointment of Luciana Borio, M.D. and Retirement of Sally W. Crawford

Luciana Borio MD is a respected physician with vast experience in advancing major regulatory and policy agendas for the United States.

Ganymed Robotics Awarded a €2.5M Grant from the EC through the EIC Accelerator Program

Ganymed Robotics is developing a radically new approach to surgical robotics by combining computer vision, a branch of artificial intelligence, and mechatronics.

By using this website you agree to accept Medical Device News Magazine Privacy Policy