News | Stroke | February 01, 2018

Study Shows Embotrap Device Usage During Stroke Treatment Yields Positive Rates Revascularization

The ARISE II clinical trial results were presented at the International Stroke Conference 2018

 

Study Shows Embotrap Device Usage During Stroke Treatment Yields Positive Rates Revascularization

February 1, 2018 – EmboTrap Device, a device designed to remove clots from the brain following an ischemic stroke, demonstrated high success rates in restoring blood flow and patients achieved high rates of functional independence, according to ARISE II (Analysis of Revascularization in Ischemic Stroke with EmboTrap Device), a new clinical trial presented at the American Stroke Association's (ASA) International Stroke Conference 2018.

Nearly 800,000 Americans have strokes each year, which are a leading cause of disability and the fifth leading cause of death. For stroke patients, the difference between life and death, and functional independence or disability, is tied to timely restoration of blood flow to the oxygen-starved brain after a stroke event occurs. In the U.S. alone, the economic burden of stroke is estimated at $34 billion annually, which includes the cost of healthcare services, medications and lost productivity.

In the ARISE II study, neurointerventional stroke physicians were able to restore blood flow in 80 percent of patients treated with EmboTrap Device within three passes (with a reperfusion grade of mTICI ≥2b). By the end of the procedure, vessels were opened in 93 percent of patients. In addition, substantial reperfusion (mTICI 2c or 3) was achieved with just a single pass in half the patients. At the 90-day follow-up, 67 percent were functionally independent. Overall, the study successfully met the prespecified endpoints.

"I believe the EmboTrap device will be an important new option for treating stroke patients," said Osama Zaidat, MD, stroke and neuroscience medical director of St. Vincent Mercy Hospital, who presented the findings at the conference. "The study results look strong with very encouraging outcomes achieved for reperfusion, modified Rankin Scale, speed to revascularization as well as the rate of first pass success."  

ARISE II was a multicenter clinical study of 228 patients, conducted to assess the safety and effectiveness of the EmboTrap Device, a stent retriever designed to retrieve a broad range of clot types. Patients eligible for the study had large vessel occlusions (LVO) and moderate to severe neurological deficits within eight hours of symptom onset.

The EmboTrap Device platform was developed by Neuravi Limited. Cerenovus acquired Neuravi Limited in April 2017. Cerenovus has submitted the ARISE II study data as part of its application to the U.S. Food and Drug Administration (FDA) for marketing clearance of EmboTrap Device in the United States. The device is already approved for use in Europe, where more than 3,000 patients have been treated.

For more information: www.neuravi.com

Related Content

Shockwave Launches Coronary Intravascular Lithotripsy in Europe
News | Cath Lab | May 30, 2018
Shockwave Medical recently announced the European commercial availability of Intravascular Lithotripsy (IVL) for...
FFR software on the GE Centricity CVIS. A trial from the 2018 EuroPCR meeting showed FFR improves long-term outcomes.
News | Cath Lab | May 29, 2018
May 29, 2018 — Ongoing controversy exists regarding the role of percutaneous coronary intervention (PCI) for stable c
SCAI Updates Consensus on Length of Stay for Percutaneous Coronary Intervention
News | Cath Lab | May 15, 2018
Revised guidelines incorporating new data on discharge criteria for patients undergoing elective percutaneous coronary...
No Benefit Found Using Sodium Bicarbonate, Acetylcysteine to Prevent Kidney Injury, the result of the PRESERVE Trial to prevent acute kidney injury (AKI), presented at SCAI 2018.  #SCAI, #SCAI2018,
Feature | Cath Lab | May 15, 2018
May 15, 2018 – The large-scale, international randomized PRESERVE clinical trial found high-risk patients for renal c
Angiogram of a STEMI patient.
News | Cath Lab | May 15, 2018
May 15, 2018 — A contemporary, real-world analysis shows lower mortality rates when culprit-only intervention is used
Recent Acquisitions Eroding Prices in Billion Dollar European Interventional Cardiology cath lab Market.
Feature | Cath Lab | May 07, 2018 | Simon Trinh and Jeffrey Wong
The European interventional cardiology market is currently valued at nearly $1.4 billion.
Videos | Cath Lab | May 07, 2018
Imran Ahmad, M.D., medical director of interventional cardiology, explains some of the new technologies his labs have
360 Photos | Cath Lab | April 20, 2018
A 360 degree view of the newest cath lab at Northwestern Medicine Central DuPage Hospital in Winfield, Ill., located
SCAI Announces Global Lecture Series for 2018 Scientific Sessions
News | Cath Lab | April 18, 2018
Many of the world’s leading interventional cardiologists and cardiovascular professionals will convene in San Diego,...
Serial coronary angiograms of the representative case treated with shockwave intravascular lithotripsy.

Figure 1. Serial coronary angiograms of the representative case treated with shockwave intravascular lithotripsy.

Feature | Cath Lab | April 16, 2018 | Azeem Latib, M.D.
Over the last decade, there have been considerable developments in procedural techniques and technology facilitating
Overlay Init