Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Ventricular Assist Device System · 1 trial · 1 indication
Therapy will be considered a success if, at the end of 12 months in the study: 1. The subject is alive; and 2. The subject has not had a stroke of Modified Rankin Score ≥ 4; and 3. The subject retains the originally implanted device, unless the device was removed due to heart recovery, or the patient is electively transplanted. Therapy will be considered a failure if, within the 12 months in the study: 1. The subject dies; or 2. The subject has a stroke of Modified Rankin Score ≥ 4; or 3. The device malfunctions or fails, requiring exchange, explantation, or urgent transplantation.
| Name | Type | Description |
|---|---|---|
| Ventricular Assist Device System | DEVICE | Ventricular Assist Device System |
Inclusion Criteria: 1. Must be ≥20 years of age at consent 2. In judgment of body size, body surface area (BSA) and anatomy by Investigator, patient can be implanted MDT-1118 VAD. 3. Patients with advanced heart failure symptoms (Class IIIB or IV) who are: (patient must meet one of the following) ...
Top 20 of 31 competitors
The Ventricular Assist Device System is used for heart failure. It is an investigational medical device being studied in patients with this condition. The system is currently in Phase 3 clinical development.
Rhythm Pharmaceuticals, Inc. (NASDAQ: RYTM) is developing the Ventricular Assist Device System. The company is conducting clinical trials to evaluate the device for the treatment of heart failure.
The Ventricular Assist Device System is in Phase 3 clinical development. It is an investigational device and has not been approved by regulatory authorities. A Phase 3 study has been completed to evaluate its use in heart failure.
The Ventricular Assist Device System has one completed Phase 3 clinical trial, NCT03884504, titled "MDT-1118 Japan DT Study." This study enrolled 10 participants with heart failure in Japan and included adults aged 20 years and older.
The Ventricular Assist Device System is associated with the study device MDT-1118, as referenced in the clinical trial NCT03884504. The trial title "MDT-1118 Japan DT Study" indicates this device was evaluated in the Phase 3 study for heart failure.