Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
PROMUS Element Plus, SYNERGY · 1 trial · 1 indication
TLF is defined as any ischemia-driven revascularization of the target lesion, myocardial infarction (Q-wave and non-Q-wave) related to the target vessel, or cardiac death.
| Arm | Type | Description |
|---|---|---|
| Promus Element Plus | ACTIVE_COMPARATOR | PROMUS Element Plus is a device/drug combination product composed of two components, a device (coronary stent system including a platinum chromium stent platform) and a drug product (a formulation of everolimus contained in a polymer coating). |
| SYNERGY | EXPERIMENTAL | SYNERGY is a device/drug combination product composed of two components, a device (coronary stent system including a platinum chromium stent platform) and a drug product (a formulation of everolimus contained in a bioabsorbable polymer coating). |
| Name | Type | Description |
|---|---|---|
| PROMUS Element Plus | DEVICE | A drug eluting coronary stent system |
| SYNERGY | DEVICE | A drug eluting coronary stent system |
Inclusion Criteria: * Subject must be at least 18 years of age * Subject (or legal guardian) understands the trial requirements and the treatment procedures and provides written informed consent before any trial-specific tests or procedures are performed * For subjects less than 20 years of age enr...
PROMUS Element Plus and SYNERGY are drug-eluting stents developed by Boston Scientific Corporation for the treatment of coronary artery disease. They are used to open narrowed or blocked coronary arteries and maintain blood flow to the heart muscle in patients with atherosclerotic lesions.
PROMUS Element Plus and SYNERGY are coronary stent systems that deliver an antiproliferative drug to the arterial wall to prevent restenosis. The specific molecular target is not disclosed in the available information, but the stents are designed to inhibit smooth muscle cell proliferation following stent implantation.
PROMUS Element Plus and SYNERGY are developed and manufactured by Boston Scientific Corporation, a publicly traded company listed on the New York Stock Exchange under the ticker symbol BSX. Boston Scientific is a global medical technology company specializing in interventional medical devices.
PROMUS Element Plus and SYNERGY are in Phase 3 clinical development for coronary artery disease. The EVOLVE II clinical trial, which assessed the SYNERGY Stent System, was a Phase 3 study that has been completed. The stents are investigational devices and are not yet approved for commercial use.
PROMUS Element Plus and SYNERGY were evaluated in the EVOLVE II clinical trial, registered as NCT01665053. This Phase 3, active-controlled, randomized study enrolled 1,684 patients with coronary artery disease across multiple countries, including the United States, Australia, Japan, and European nations. The trial has been completed.
PROMUS Element Plus and SYNERGY are both coronary stent systems developed by Boston Scientific for the treatment of coronary artery disease. They are related products in the company's stent portfolio, with SYNERGY being the specific stent system evaluated in the EVOLVE II clinical trial. The relationship between the two names indicates they are part of the same product family.