Important Safety Information

The Neovasc Reducer System comprises the Reducer implantable device pre-mounted on the Reducer Balloon Catheter. The Reducer is a single-use implantable device with an INTENDED USE of creating a permanent and controlled narrowing of the coronary sinus (CS), to improve perfusion to ischemic myocardium for reduction of angina symptoms in patients with refractory angina pectoris and objective evidence of reversible myocardial ischemia, who have limited treatment options and are thus referred to as ‘no-option’ patients. These patients are either not amenable to, or are high risk for, revascularization by coronary artery bypass grafting (CABG) or by percutaneous coronary intervention (PCI).

The Reducer System is CONTRAINDICATED in patients with:

  • Recent (within 3 months) acute coronary syndrome
  • Recent (within 6 months) PCI revascularization by stent or CABG
  • Recent (within 30 days) unsuccessful PCI
  • Unstable angina (recent onset angina, crescendo angina, or rest angina with ECG changes) during the last 30 days
  • Decompensated congestive heart failure (CHF) or hospitalization due to CHF during the last 3 months
  • Left ventricular ejection fraction of less than 30%
  • Mean right atrial pressure greater than 15mm Hg
  • Anomalous or abnormal CS anatomy (e.g., tortuosity, aberrant branch, persistent left superior vena cava [SVC]) as demonstrated by angiogram
  • CS diameter at the site of planned implantation greater than 13mm or less than 9.5mm as measured by angiogram
  • Severe chronic obstructive pulmonary disease (COPD) indicated by a forced expiratory volume in one second that is less than 55 percent of the predicted value
  • Severe valvular heart disease
  • A pacemaker electrode in the coronary sinus
  • Tricuspid valve replacement or repair
  • Chronic renal failure (serum creatinine >2mg/dL), and/or on chronic hemodialysis
  • Moribund, or with comorbidities limiting life expectancy to less than one year
  • Known severe reaction to required procedural medications
  • Known allergy to stainless steel or nickel
  • Magnetic Resonance Imaging (MRI) within 8 weeks of Reducer implantation

 

There are POTENTIAL ADVERSE EVENTS that may be associated with the procedure and implant include, but are not limited to, the following:

  • access site complications
  • allergic reaction
  • arrhythmias
  • bleeding event
  • cardiac valve injury
  • conduction disturbances
  • device or vessel occlusion
  • device fracture, malposition, migration or embolization
  • dissection
  • embolism
  • hypotension / hypertension
  • infection
  • ischemic event
  • myocardial damage
  • neurological event
  • perforation / rupture of coronary sinus, right atrium, or internal jugular vein
  • pulmonary edema
  • pyrogenic, immunological or toxicological reaction
  • respiratory failure
  • spasm of coronary sinus or jugular vein
  • vascular event

 

Judicious selection of patients is necessary.  Administration of appropriate anticoagulant, antiplatelet and coronary vasodilator therapy is critical to successful Reducer implantation and follow-up. Only physicians who have received appropriate training should perform implantation of the Reducer.

 

Please refer to the product Instructions for Use for a complete listing of indications, contraindications, warnings, precautions and potential complications.