Rx Only

Brief Summary: Prior to using these devices, please review the Instructions for Use for a complete listing of indications,  contraindications, warnings, precautions, potential adverse events and directions for use

Indications: The Aveir™ Leadless Pacemaker system is indicated for patients with significant bradycardia and:

▪ Normal sinus rhythm with rare episodes of A-V block or sinus arrest

▪ Chronic atrial fibrillation

▪ Severe physical disability

Rate-Modulated Pacing is indicated for patients with chronotropic incompetence, and for those who would benefit from increased stimulation rates concurrent with physical activity.

Intended Use: The Aveir™ Leadless Pacemaker (LP) is designed to provide bradycardia pacing as a pulse generator with built-in battery and electrodes for implantation in the right ventricle. The LP is intended to provide sensing of intrinsic cardiac signals and delivery of cardiac pacing therapy to the target patient population.

The Aveir™ Delivery Catheter system is intended to be used in the peripheral vasculature and the cardiovascular system to deliver and manipulate an LP. Delivery and manipulation includes implanting an LP within the target chamber of the heart.

Contraindications: Use of the Aveir™ Leadless Pacemaker is contraindicated in these cases:

Use of any pacemaker is contraindicated in patients with a co-implanted ICD because high-voltage shocks could damage the pacemaker and the pacemaker could reduce shock effectiveness.

Single-chamber ventricular demand pacing is relatively contraindicated in patients who have demonstrated pacemaker syndrome, have retrograde VA conduction, or suffer a drop in arterial blood pressure with the onset of ventricular pacing.

Programming of rate-responsive pacing is contraindicated in patients with intolerance of high sensor-driven rates.

Use is contraindicated in patients with an implanted vena cava filter or mechanical tricuspid valve because of interference between these devices and the delivery system during implantation.

Persons with known history of allergies to any of the components of this device may suffer an allergic reaction to this device. Prior to use on the patient, the patient should be counseled on the materials (listed in Product Materials section in IFU) contained in the device and a thorough history of allergies must be discussed.

Adverse Events: Potential complications associated with the use of the Aveir™ Leadless Pacemaker system are the same as with the use of single chamber pacemakers with active fixation pacing leads including, but not limited to: Cardiac perforation, Cardiac tamponade, Pericardial effusion, Pericarditis, Valve damage and/or regurgitation, Heart failure, Pneumothorax/hemothorax, Cardiac arrhythmias, Diaphragmatic/phrenic nerve stimulation / extra-cardiac stimulation, Palpitations, Hypotension, Syncope, Cerebrovascular accident, Infection, Hypersensitivity reaction to device materials, medications, or direct toxic effect of contrast media on kidney function, Pacemaker syndrome, Inability to interrogate or program the LP due to programmer or LP malfunction, Intermittent or complete loss of pacing and/or sensing due to dislodgement or mechanical malfunction of the LP (non-battery related), Loss of capture or sensing due to embolization or fibrotic tissue response at the electrode, Increased capture threshold, Inappropriate sensor response, Interruption of desired LP function due to electrical interference, either electromyogenic or electromagnetic, Battery malfunction/ premature battery depletion, Device-related complications (Premature deployment, Device dislodgement/embolization of foreign material, Helix distortion), Death.

As with any percutaneous catheterization procedure, potential complications include, but are not limited to: Vascular access complications (such as perforation, dissection, puncture, groin pain), Bleeding or hematoma, Thrombus formation, Thromboembolism, Air embolism, Local and systemic infection, Peripheral nerve damage, General surgery risks and complications from comorbidities (such as hypotension, dyspnea, respiratory failure, syncope, pneumonia, hypertension, cardiac failure, reaction to sedation, renal failure, anemia, and death).

By Prescription Only

Brief Summary: Prior to using these devices, please review the Instructions for Use for a complete listing of indications, contraindications, warnings, precautions, potential adverse events and directions for use.

CardioMEMS™ HF System Indications and Usage: The CardioMEMS HF System is indicated for wirelessly measuring and monitoring pulmonary artery pressure and heart rate in NYHA Class II or III heart failure patients who either have been hospitalized for heart failure in the previous year and/or have elevated natriuretic peptides. The hemodynamic data are used by physicians for heart failure management with the goal of controlling pulmonary artery pressures and reducing heart failure hospitalizations.

Contraindications: The CardioMEMS™ HF System is contraindicated for patients with an inability to take dual antiplatelet or anticoagulants for one month post implant.

CardioMEMS™ HF System Potential Adverse Events:  Potential adverse events associated with the implantation procedure include, but are not limited to, the following: air embolism, allergic reaction, infection, delayed wound healing, arrhythmias, bleeding, hemoptysis, hematoma, nausea, cerebrovascular accident, thrombus, cardiovascular injury, myocardial infarction, death, embolization, thermal burn, cardiac perforation, pneumothorax, thoracic duct injury and hemothorax.

myCardioMEMS™ Mobile App Limitations: Patients must use their own Apple‡ or Android‡ mobile device to receive and transmit information to the myCardioMEMS™ Mobile App. To do so the device must be powered on, app must be installed and data coverage (cellular or Wi-Fi‡) available. The myCardioMEMS™ App can provide notification of medication adjustments and reminders, requests for lab work and acknowledgment that the PA pressure readings have been received. However there are many internal and external factors that can hinder, delay, or prevent acquisition and delivery of the notifications and patient information as intended by the clinician. These factors include: patient environment, data services, mobile device operating system and settings, clinic environment, schedule/configuration changes, or data processing.