Skip to main content

My account

Boston Scientific accounts are for healthcare professionals only.

Create an account to access online training and education on EDUCARE, manage your customer profile, and connect with customer support and service teams.

My Boston Scientific account

Access your online applications and manage your customer profile.

Manage my Boston Scientific account

Quick Links

Contact a representative Online education and training Order products online Reimbursement resources Return a product Customer support

Call customer care

1 (888) 272-1001

SYNERGY MEGATRON™ Indications, Safety and Warnings

Return to product detail page

CAUTION: Federal law (USA) restricts this device to sale by or on the order of a licensed practitioner. Prior to use, please refer to all applicable “Instructions for Use” for more information on Intended Use/Indications for Use, Contraindications, Warnings, Precautions, Potential Adverse Events, and Operator’s Instructions.

INDICATIONS FOR USE 

The SYNERGY MEGATRON Everolimus-Eluting Platinum Chromium Coronary Stent System is indicated for improving luminal diameter in patients, including those at high risk for bleeding, with diabetes mellitus, with symptomatic heart disease, stable angina, unstable angina, ST elevation MI (STEMI), non-ST elevation MI or documented silent ischemia due to atherosclerotic lesions in native coronary arteries ≥3.50 mm to ≤5.00 mm in diameter in lesions ≤28 mm in length. 

CONTRAINDICATIONS 

Use of the SYNERGY MEGATRON Everolimus-Eluting Platinum Chromium Coronary Stent System is contraindicated in patients with known hypersensitivity to: 

  • 316L stainless steel, platinum, chromium, iron, nickel or molybdenum 
  • Everolimus or structurally-related compounds 
  • The polymer or their individual components (see section 2.4.2 Polymer Carrier) Coronary Artery Stenting is contraindicated for use in: 

Coronary Artery Stenting is contraindicated for use in:

  • Patients judged to have a lesion that prevents complete inflation of an angioplasty balloon or proper placement of the stent or delivery device. 
  • Patients with uncorrected bleeding disorders or patients who cannot receive anticoagulation or antiplatelet aggregation therapy (see Section 6.2, Pre- and Post-Procedure Antiplatelet Regimen for more information). 

PRECAUTIONS

  • Care should be taken to control the position of the guide catheter tip during stent delivery, deployment and balloon withdrawal. Ensure balloon is fully deflated before delivery system withdrawal. Larger and longer balloons will take more time to deflate than smaller and shorter balloons. Allow adequate time, at least 30 seconds, for complete balloon deflation. Before withdrawing the stent delivery system, visually confirm complete balloon deflation under fluoroscopy. Failure to do so may cause increased stent delivery system withdrawal forces and result in guide catheter movement into the vessel and subsequent arterial damage. 
  • Compared to use within the specified Indications for Use, the use of drug eluting stents in patients and lesions outside of the labeled indications may have an increased risk of adverse events, including stent thrombosis, stent embolization, MI or death. When treating such patients, physicians should be aware of this increased risk and consider available data and the limitations of such data. 

 

POTENTIAL ADVERSE EVENTS

Potential adverse events (in alphabetical order) which may be associated with the use of a coronary stent in a coronary vessel include but are not limited to: 
  • Allergic or adverse reaction (including medications, anesthesia, contrast, or device materials) 
  • Angina 
  • Arrhythmias, including ventricular fibrillation, ventricular tachycardia and heart block 
  • Bleeding including hemorrhage or hematoma (possibly requiring transfusion or additional intervention) 
  • Cardiac failure leading to low cardiac output (cardiogenic shock) or pulmonary edema 
  • Death 
  • Emboli (including air, tissue, thrombus, or device materials) 
  • Fever and pyrogen reaction 
  • Heart failure 
  • Hypotension/hypertension 
  • Infection, local or systemic 
  • Myocardial infarction 
  • Pain or inflammation 
  • Pericarditis, pericardial effusion, or tamponade 
  • Radiation injury 
  • Renal insufficiency or failure 
  • Respiratory insufficiency or failure 
  • Restenosis or late acquired malapposition of treated segment  
  • Stent placement issues including geographic miss, malapposition, migration, or embolization 
  • Stent thrombosis / vessel occlusion 
  • Stroke/cerebrovascular accident/transient ischemic attack 
  • Vessel injury (including access-site) such as spasm, lymphatic problems, pseudoaneurysm, arteriovenous fistula, trauma, dissection, occlusion, perforation, and rupture 
 
Zortress, the oral formulation of everolimus developed by Novartis Pharmaceuticals Corporation, has been evaluated in clinical trials and is approved in the United States for the prevention of organ rejection in adult kidney transplant recipients at the dose of 1.5 mg/day. Outside the U.S., Zortress is sold under the brand name, Certican, in more than 70 countries. Everolimus is also approved in the United States under the name of Afinitor for patients with advanced renal cell carcinoma (cancer), after failure of treatment with sunitinib or sorafenib, at doses of 5 to 20 mg/day when taken by mouth. The following list includes the known risks of everolimus at the oral doses listed above. The amount of drug that circulates in the bloodstream following implantation of a SYNERGY MEGATRON Stent is several folds lower than that obtained with oral doses (1.5 mg to 20 mg/day, see Section 7.2, Pharmacokinetics). Adverse events associated with daily oral administration of everolimus (or potential adverse events not captured above, that may be unique to the everolimus drug coating) can be found in the labeling for finished pharmaceuticals containing everolimus, such as Afinitor or Zortress. 
Top