Important Risk Information

Intended Use

The Cordella Pulmonary Artery Sensor System is intended to measure, record and transmit pulmonary artery pressure (PAP) data from NYHA Class III heart failure patients who are at home on diuretics and guideline-directed medical therapy (GDMT), as well as have been stable for 30 days on GDMT. The device output is meant to aid clinicians in the assessment and management of heart failure, with the goal of reducing heart failure hospitalizations.

Contraindications

The Cordella Pulmonary Artery Sensor System is contraindicated for patients with an inability to take dual antiplatelet or anticoagulants for one month post implant.

Clinical Considerations for Patient Selection

The following patients may not be appropriate for implantation of the Cordella PA Sensor System:

• Patients with an active infection
• Patients with a history of recurrent pulmonary embolism (≥2 episodes within 5 years) and/or recent deep vein thrombosis (within the past 3 months)
• Patients with known coagulation disorders
• Patients with a hypersensitivity or allergy to platelet aggregation inhibitors including aspirin, clopidogrel, prasugrel, and ticagrelor
• Patients with a known history of life threatening allergy to contrast dye
• Patients unable to tolerate a right heart catheterization
• Patients with a Glomerular Filtration Rate (GFR) <25 ml/min or who are on chronic renal dialysis
• Patients who have been implanted with a Cardiac Resynchronization Device (CRT)-Pacemaker (CRT-P) or CRT-Defibrillator (CRT-D) within the past 3 months.

 

Warnings

 

Implantation Procedure:

• DO NOT attempt to modify, disassemble, or otherwise alter the Cordella Pulmonary Artery Sensor System.
• A continuous heparin drip should be used to prevent clotting. The ACT should be at least 200 sec from the time of Delivery System insertion until the Stability Sheath is removed.
• DO NOT expose the Cordella Sensor to therapeutic levels of ultrasonic energy.
• After the procedure, it is critical for the patient to adhere to prescribed anticoagulation, antiplatelet, and other medications from the physician.
• DO NOT use an automated power injector through the Stability Sheath.
• DO NOT insert the Cordella Sensor by pushing the Delivery System without supporting the Cordella Sensor from behind as this may result in damage to the device.
• If gripping the Cordella Sensor is necessary, grab only by the sides and not the top surface as this may cause Sensor damage.

 

Reader and Docking Station:

• The Reader is suitable for home healthcare environments and professional healthcare facilities except near active heart failure hospital

• equipment and the radiofrequency (RF) shielded room of a medical electrical (ME) system for magnetic resonance imaging, where the intensity
• of electromagnetic (EM) disturbance is high.
• The Reader and Docking Station should not be used adjacent to or stacked with other equipment. If it is necessary to operate the components
• adjacent to or stacked with other equipment, verify that the system is operating normally in the configuration in which it will be used.
• DO NOT expose any power accessories, the Reader, or the Docking Station to food or liquids.
• DO NOT use myCordella in the presence of explosive or flammable anesthetic agents.
• Power cables may pose a tripping hazard. Be mindful of cords crossing walkways.
• DO NOT position power cables in any manner that may cause entanglement or strangulation.
• Other equipment generating electromagnetic fields may interfere with the Reader. When possible, avoid using the Reader while simultaneously using other equipment such as: patient monitoring systems, chest ECG leads, motors on motorized beds, pagers, RFID tags, laptop computers, tablets, cell phones, cordless phones, wireless routers, continuous glucose monitors on the right arm, air conditioners within
• ~5 feet (1.5m), UHF RFID tags within ~2 feet (0.6m), and RFID equipment operating at 2.45 GHz within ~4 feet (1.2m).
• The Reader requires special precautions regarding electromagnetic compatibility (EMC) and needs to be placed into service according to the
• EMC information provided. If interference is noted while taking a reading (e.g. if CalEQ and Reader continue to disconnect), remove or stop using the interfering equipment.
• Portable RF communications equipment (including peripherals such as antenna cables and external antennas) should be used no closer than ~5 feet (1.5 m) from any part of the Reader. Otherwise, degradation of the performance of the Reader could result.
• The patient should not have necklaces, jewelry, shirt pocket contents, metal objects, and near field communication objects in the vicinity of the reading location while taking a reading.
• If the skin becomes red, warm, or irritated, immediately stop using the Reader and contact Customer Service and notify the patient’s primary care provider (PCP).
• DO NOT use more than one Reader in the same general vicinity at one time, as use of multiple Readers at once may cause them to interfere with each other.
• To ensure accuracy, the Sensor must be recalibrated approximately every three years using a RHC procedure.

 

Calibration Equipment:

• CalEQ must be operated by trained Endotronix personnel only.
• The CalEQ is suitable for professional healthcare facilities except for near active heart failure hospital equipment and the radiofrequency (RF).

• shielded room of a medical electrical (ME) system for magnetic resonance imaging, where the intensity of electromagnetic (EMI) disturbance is high.
• The CalEQ should not be used adjacent to or stacked with other equipment. If it is necessary to operate the components adjacent to or stacked with other equipment, verify that the system is operating normally in the configuration in which it will be used.
• Portable RF communications equipment (including components such as antenna cables and external antennas) should be used no closer than ~5 feet (1.5m) from any part of the CalEQ. Otherwise, degradation of the performance of the CalEQ could result.
• Only use CalEQ accessories, cables, and/or components that have been supplied by Endotronix. Using other unlabeled accessories, cables, and/or components may affect patient safety and measurement accuracy.
• The CalEQ should not be used to obtain pulmonary artery pressure and/or pulmonary artery pressure derived parameters for diagnostic purposes.
• Only connect CalEQ to 60601-1 compliant patient monitors. Using non-compliant patient monitors may affect patient safety and measurement accuracy.
• To avoid risk of electric shock, the CalEQ must only be connected to a supply main with protective earth.
• DO NOT plug additional devices into the CalEQ power strip.

 

Precautions

• Only use the side-port of the Stability Sheath for injection and aspiration. The guidewire lumen should not be used for aspiration or injection after initial flushing.
• The implant procedure is an adjunct to a standard (RHC) procedure. All standard protocols for the RHC should be followed.
• Explanting the Cordella Sensor after implantation is not recommended.
• If there is evidence of a change in device performance, please contact Customer Service.
• The Cordella Sensor and Delivery System are only compatible with a 14 French introducer or larger. Use of a smaller introducer may damage the Cordella Sensor or Delivery System product and may prevent introduction. The use of peel away introducers is not recommended.
• Torquing the Stability Sheath with the Torque Catheter removed may result in kinking of the Stability Sheath and may impact the reliability of a fluid-filled pressure measurement.
• Precaution should be taken to avoid damage to the Cordella Sensor prior to implantation. It is an all glass enclosure and it is fragile. Only remove from packaging when ready to start a procedure. Take care to avoid shock or drop to the distal end of the Delivery System where the Cordella Sensor is pre-mounted. Care should be taken to limit contact with the Cordella Sensor prior to insertion through the introducer sheath.
• Avoid squeezing or pinching the body of the Cordella Sensor if at all possible.
• DO NOT place more than one Cordella Sensor in a patient. The two Cordella Sensors may interfere with each other and limit the ability to obtain accurate readings.
• Activities that may expose the patient to ambient pressure extremes may affect device performance. If the patient plans to SCUBA dive, please contact Customer Service.
• Accuracy of the Cordella Pulmonary Artery Sensor System is slightly affected by large changes in elevation between the initial baseline calibration and subsequent measurements. Readings may lose accuracy when taken at >2000m of elevation. If a patient plans to travel or move to a location at >2000m of elevation, contact Customer Service.
• The CalEQ should not be used in the sterile field.
• DO NOT expose any components of myCordella to water or liquids. Contact Customer Service for a replacement if any components are exposed to liquids.
• DO NOT drop the Reader. Handle with care.
• If dropped, the Reader battery may be exposed. If the battery is exposed, contact Endotronix immediately for a replacement Reader. Any damage to the Reader may result in an inaccurate reading.
• DO NOT use the Reader if the plastic casing has been damaged or any component becomes dislodged.
• If the Reader label becomes compromised, contact Endotronix Customer Service
• CalEQ and the Reader contain a Lithium-ion battery.
• LVAD and Continuous Glucose Monitor compatibility with the Cordella System has not been assessed.
• Improper or rapid removal of the Delivery System may cause vessel damage.

 

Potential Adverse Events

Potential risks associated with the overall procedure include potential access complications associated with standard right heart catheterization, the potential risks of conscious sedation, and the use of angiography:

• Allergic reaction
• Arrhythmias
• Bleeding complications (which may require transfusion)
• Cardiac arrest
• Chest pain
• Death
• Device embolization/migration
• Device explant
• Emergent or urgent cardiac, vascular, and/or other surgery necessitated by the device or implant procedure (e.g., coronary sinus lead revision)
• Endocarditis or device infection
• Entry site complications (e.g., hematoma, dissection)
• Fracture of a component of the device /system that may or may not lead to serious injury or surgical intervention.
• Gastrointestinal bleed
• Hemoptysis
• Hypo or hypertension
• Infection or fever
• Lead dislodgement
• Peripheral embolism/thrombus
• Pulmonary embolism/pulmonary occlusion
• Pseudoaneurysm of the vein
• Radiation exposure
• Reaction to contrast media/medication
• Renal insufficiency or failure
• Respiratory distress or failure (breathing problems)
• Right atrial/ventricular and coronary sinus lead dislodgement
• Sepsis
• Valvular injury (tricuspid and/or pulmonary)
• Vascular complications (e.g., venous dissection, perforation, rupture, arteriovenous fistula,)
• Vessel trauma which may require surgical repair
• Worsening heart failure