With Gallant, Doctors Can Keep Pace With Your Heart

For people living with arrythmias, Gallant ICD and the myMerlinPulse app pay off on the promise of connected care.

Healthy Heart | Feb. 18, 2021

Among the treatment options your doctor can offer, nobody wants the silent treatment.

That's what happens when the promise — and expectation — of connected care via telehealth goes unfulfilled. It's a letdown that can be life-threatening for the millions living with heart arrythmias.

For those managing their care with our Gallant implantable cardioverter defibrillator (ICD) and cardiac resynchronization therapy defibrillator (CRT-D) devices — which have Bluetooth® connectivity and pair with an intuitive myMerlinPulse™ app for Apple and Android™ — they aren't left staring at their phones.

"When we think about traditional remote monitoring, we have a box that sits at the patient's nightstand. The patient has no feedback until they see a light blink. They're not sure what that light means. They have no understanding if the device has been transmitting information," said Dr. Harish Manyam, chief of cardiology and head of electrophysiology at Erlanger Hospital in Chattanooga, Tenn., the first physician in the U.S. to implant the Gallant device.

That's how it was, a reality of yesterday.

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But Gallant's lineage of devices is a modern family, with all the smartphone connectivity the world expects.

People using Gallant along with the myMerlinPulse app know their devices are working. That their information is being securely shared with their doctors from anywhere in the world. And that they can confidently have meaningful conversations with their healthcare providers. All through the convenience of an app on their mobile devices.

That's what Gallant offers now, the new reality.

"Patients are engaged. People want to know what's going on with them," Manyam said. "I don't feel well, how do I send this to my doctor? With an app, they're able to transmit information real time, when they have issues and then get some feedback. That's what people want."

It doesn't just give people with Gallant what they want.

It also gives doctors what they need to provide the best care, making the most of every second.

"Gallant is a powerfully connected device. We're talking about a device that not only is able to deliver life-saving treatment, it's able to actually send data to us," Manyam said. "And so when the patient arrives in the emergency room, we already know what's going on with them."

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Gallant is not just a reflection of where the world has gone technologically.

It's also helping you get where you want to go in the world geographically.

Gallant — available in the U.S. and Europe — and its app is opening a world of possibilities for people living with arrythmias. No longer are you all-but tethered to that box on your nightstand, as Manyam describes.

You can see it in action. And from that, you can easily see yourself in action, doing the things you want to do, visiting the places you want to visit, being the person you want to be.

All without compromising your Gallant battery's longevity or MRI compatibility.

Avi Fischer, M.D., divisional vice president and chief medical officer for Abbott's Cardiac Rhythm Management business, agrees.

"The positive impact of remote monitoring has been proven repeatedly. Our Gallant system provides people the ability to connect to their doctor anytime, even while away from home, and reinforces our commitment to incorporate advanced technologies that will help improve engagement between patients and caregivers with doctors," Fischer said.

So get engaged. Make a long-term commitment to your health. With Gallant and the myMerlinPulse app, your doctor will be there with you every step of the way. No silent treatment.

Note: Bluetooth is a registered trademark of Bluetooth SIG, Inc. iOS is a trademark of Cisco Technology, Inc. Android is a trademark of Google LLC.

Important Safety Information

GALLANT, ENTRANT

Rx Only

Brief Summary: This product is intended for use by or under the direction of a Physician. 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.

Intended Use: The Implantable Cardioverter Defibrillator (ICD) and Cardiac Resynchronization Therapy Defibrillator (CRT-D) devices are intended to provide ventricular antitachycardia pacing and ventricular cardioversion/defibrillation. The CRT-D devices are also intended to resynchronize the right and left ventricles.

The myMerlinPulse™ mobile application is intended for use by people who have an Abbott Medical implanted heart device and access to a mobile device. The app provides remote monitoring capability of the implanted heart device by transmitting information from the patient’s implanted heart device to the patient’s healthcare provider.

Indications: The ICD and CDT-D devices are indicated for automated treatment of life-threatening ventricular arrhythmias. CRT-D devices are also indicated to treat symptoms in patients who have congestive heart failure with ventricular dyssynchrony.

In addition, dual chamber ICD and CRT-D devices with the AT/AF detection algorithm are indicated in patients with atrial tachyarrhythmias or those patients who are at significant risk of developing atrial tachyarrhythmias.

MR Conditional ICDs and CRT-Ds are conditionally safe for use in the MRI environment when used in a complete MR Conditional system and according to instructions in the MRI-Ready Systems manual. Scanning under different conditions may result in severe patient injury, death or device malfunction.

The myMerlinPulse™ mobile application is indicated for use by patients with supported Abbott Medical implanted heart devices.

Contraindications: Contraindications for use of the pulse generator system include ventricular tachyarrhythmias resulting from transient or correctable factors such as drug toxicity, electrolyte imbalance, or acute myocardial infarction.

The myMerlinPulse™ mobile application is contraindicated for use with any implanted medical device other than supported Abbott Medical implanted heart devices.

Adverse Events: Possible adverse events associated with the implantation of the pulse generator system include the following: Arrhythmia (for example, accelerated or induced), Bradycardia, Cardiac or venous perforation, Cardiac tamponade, Cardiogenic shock, Death, Discomfort, Embolism, Endocarditis, Erosion, Exacerbation of heart failure, Excessive fibrotic tissue growth, Extracardiac stimulation (phrenic nerve, diaphragm, pectoral muscle), Extrusion, Fluid accumulation within the device pocket, Formation of hematomas, cysts, or seromas, Heart block, Hemorrhage, Hemothorax, Hypersensitivity, including local tissue reaction or allergic reaction, Infection, Keloid formation, Myocardial damage, Nerve damage, Occlusion/Thrombus, Pericardial effusion, Pericarditis, Pneumothorax, Pulmonary edema, Syncope, Thrombosis, Valve damage. Complications reported with direct subclavian venipuncture include pneumothorax, hemothorax, laceration of the subclavian artery, arteriovenous fistula, neural damage, thoracic duct injury, cannulation of other vessels, massive hemorrhage and rarely, death. Among the psychological effects of device implantation are imagined pulsing, depression, dependency, fear of premature battery depletion, device malfunction, inappropriate pulsing, shocking while conscious, or losing pulse capability. Possible adverse device effects include complications due to the following: , Abnormal battery depletion, Conductor fracture, Device-programmer communication failure, Elevated or rise in defibrillation/cardioversion threshold, Inability to defibrillate or pace, Inability to interrogate or program due to programmer or device malfunction, Incomplete lead connection with pulse generator, Inhibited therapy including defibrillation and pacing, Inappropriate therapy (for example, shocks and antitachycardia pacing [ATP] where applicable, pacing), Interruption of function due to electrical or magnetic interference, Intolerance to high rate pacing (for example dyspnea or discomfort), Lead abrasion, Lead fracture, Lead insulation damage, Lead migration or lead dislodgement, Loss of device functionality due to component failure, Pulse generator migration, Rise in DFT threshold, Rise in pacing threshold and exit block, Shunting of energy from defibrillation paddles, System failure due to ionizing radiation. Additionally, potential adverse events associated with the implantation of a coronary venous lead system include the following: Allergic reaction to contrast media, Breakage or failure of implant instruments, Prolonged exposure to fluoroscopic radiation, Renal failure from contrast media used to visualize coronary veins. Refer to the User's Manual for detailed intended use, indications, contraindications, warnings, precautions and potential adverse events.

No potential adverse events have been identified with use of the myMerlinPulse™ mobile application.