Clinical Trials
18
2 active
Approvals
0
Total approvals
Agencies
0
Regulatory bodies
Founded
1889
Active, not recruiting
1
5.6%
Completed
7
38.9%
Not yet recruiting
1
5.6%
Recruiting
2
11.1%
Terminated
3
16.7%
Unknown
4
22.2%
No approval data available
- CorFlow Therapeutics received FDA investigational device exemption approval for its MOCA-II pivotal trial, enabling enrollment of over 200 STEMI patients at U.S. and European research institutions. - The trial will validate the diagnostic accuracy of CorFlow's CoFl system in detecting microvascular obstruction during primary PCI procedures, comparing results to cardiac MRI reference standards. - More than half of STEMI heart attack patients have microvascular obstruction, which drives adverse clinical outcomes, yet no approved diagnostic technologies currently exist for real-time detection during interventions. - The technology represents a potential breakthrough in heart attack care, as someone experiences a heart attack every 30 seconds in the U.S. with approximately 800,000 cases annually.
- Surgeons at The Christ Hospital successfully implanted the Bivacor Total Artificial Heart in a patient awaiting a heart transplant, marking the fourth such procedure worldwide. - The Bivacor device serves as a temporary replacement for the complete function of the heart, acting as a bridge until a donor heart becomes available. - The artificial heart is currently undergoing early-stage FDA approval and is part of a clinical study to assess its potential to revolutionize heart transplantation. - The recipient, Mike Herrman, experienced significant improvement while using the device for 15 days, highlighting its potential to enhance the quality of life for patients with severe heart conditions.
