Safety Information

Device: V-Wave Ventura Interatrial Shunt

Indications For Use:

The Ventura Interatrial Shunt System is indicated for NYHA Class III heart failure patients who remain symptomatic despite guideline directed medical therapy and have a left ventricular ejection fraction of ≤40% to reduce the combined risk of morbidity and mortality.

CONTRAINDICATIONS

The V-Wave Ventura Interatrial Shunt System is contraindicated for the following:

• Patients with an LVEF > 40%
• Patients with a tricuspid annular plane systolic excursion < 12 OR a right ventricular fraction area change ≤ 25%.
• Patients having a mitral repair procedure performed within the last three (3) months.
• Patients with a tamponade, or large pericardial effusion
• Patients that have had a stroke, transient ischemic attack (TIA), pulmonary thromboembolism, deep vein thrombosis (DVT) in the last 6 months.
• Patients with unresolved, non-organized or mobile intracardiac thrombus or central venous thrombus.
• For left sided heart failure, patients that are more likely to benefit from LVAD or cardiac transplantation.
• For left sided heart failure, Patients in which the right atrial pressure (RAP) > pulmonary capillary wedge pressure (PCWP) or left atrial pressure (LAP) during the right heart catheterization (RHC) assessment.
• Patients with a patent Foramen Ovale (PFO) or atrial septal defect (ASD) with more than trace shunting, or prior repair of ASD or PFO by means other than stitching.
• Patients with anatomical anomalies that preclude proper implantation of the device across the fossa ovalis, including fossa ovalis thickness >6mm, fossa ovalis length <10mm, inadequate vascular access or inability to perform safe transseptal catheterization of the left atrium.
• Patients with known allergies to nickel, titanium, ePTFE, or other device materials.
• Unable to tolerate procedural anticoagulation regimen and/ or post procedural anticoagulation therapy for right-sided heart failure /antiplatelet therapy for leftsided heart failure.
• Patients with active bacterial endocarditis or other active infections.
• Patients with clinical or hemodynamic instability.
• For left-sided heart failure, patients with a mean PCWP >35 mmHg, not correctable by medical therapy
• For left-sided heart failure, patients with a pulmonary artery systolic pressure (PASP) >70 mmHg associated with pulmonary vascular resistance (PVR) >4.0 Wood Units, that cannot be reduced to a PVR ≤4 Wood Units by acute vasodilator therapy.
• Patients assessed to be unable to lie flat and be safely sedated or put under general anesthesia and tolerate transseptal catheterization and ancillary catheterization / implant procedures required for V-Wave Ventura shunt implantation.

WARNINGS

• Read all instructions carefully. Failure to follow these instructions, warnings and precautions may lead to device damage or patient injury.
• Implantation of the V-Wave Ventura Interatrial shunt should be performed only by physicians experienced in transseptal cardiac catheterization procedures and trained in the proper use of the system by V-Wave, Ltd. or its designees.
• Implantation of the V-Wave Ventura Interatrial shunt should only be attempted in conjunction with its delivery system and the V-Wave Ventura 15 Fr Introducer Sheath or Oscor Breezeway II Introducer Sheath G140079045L10 / G140079045L08
• The implant placement procedure should only be performed at institutions where emergency surgery can be readily arranged (either within the implanting institution, or via patient transport to an alternate institution with emergency surgery capability). Emergency surgery may be required in case of cardiac or vascular perforation or if the Shunt is embolized and cannot be retrieved with catheter-based methods.
• Failure to administer therapeutic doses of intravenous anticoagulation during implantation may result in thromboembolic complications such as stroke.
• The V-Wave Ventura System is a single use device and is intended for single patient use only. Do not re-sterilize or reuse the interatrial shunt, the delivery system or the introducer sheath. After use, dispose of the system according to local regulations and institutional procedures.
• The system should be handled carefully per these instructions and only with the tools provided.
• Inspect all System components prior to use. DO NOT use if labelling is illegible or missing, if sterilization has been compromised, if device packaging has been damaged or the use by date has passed.

PRECAUTIONS

• Long term durability of interatrial shunting has not been established. Regular medical follow-up is advised to evaluate the performance of the interatrial shunt.
• Peri-procedure antibiotic prophylaxis is recommended for patients at risk for prosthetic device infection or endocarditis.
• Do not contact the shunt or any of the delivery system components with cotton, cotton swabs or powdered gloves.
• Implantation should only be performed in conjunction with high resolution catheterization laboratory quality fluoroscopy and either transesophageal or intracardiac echocardiography to assess the septal anatomy and for system visualization.
• Patients should be eligible for emergency open heart surgery.
• Safety and effectiveness have not been established for left-sided heart failure patients:
  • Who are pregnant.
  • With a Left Ventricular End-Diastolic Diameter (LVEDD) > 8cm.
  • With constrictive pericarditis or infiltrative cardiomyopathy.
  • With a prior cardiac transplant.
  • With an estimated glomerular filtration rate (eGFR) <25 ml/min/1.73 m2 by the MDRD method, or not responsive to diuretics, or is receiving dialysis.
  • Patients with a documented liver function test result (transaminases, total bilirubin, or alkaline phosphatase) ≥ 3 times upper limit of normal.
  • Patients with a cardiac index <1.5 L/m2, not secondary to volume depletion.
  • Patients with an atrial septal aneurysm defined as ≥ 10 mm of phasic septal excursion into either atrium or a sum total excursion of ≥ 15 mm during the cardiorespiratory cycle, with a base of ≥ 15 mm.
  • With the Shunt implanted in a location other than the fossa ovalis.
• From prior studies with atrial septostomy, for right-sided heart failure, safety and effectiveness has not been established for patients with the following characteristics or conditions:
  • Left Ventricular End-Diastolic Pressure, LAP or mean PCWP > 15mmHg
  • Right Atrial Pressure (RAP) > 20mmHg
  • Cardiac Index (CI) < 1.5 liters/min/m2
  • Intracardiac thrombus
  • Resting oxygen saturation of < 90% at sea level

• For right-sided heart failure safety has not been established with coexisting left-sided heart failure dysfunction.
• The results of deploying Shunt in a location other than the fossa ovalis are unknown.