It’s Draft Day: Damar Hamlin Helps Build the Abbott HeartMates Team
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NORTHAMPTON, MA / ACCESSWIRE / April 23, 2024 / Abbott
Eleven new HeartMates with 11 inspiring stories recognized at Abbott HeartMates Draft Day event in NYC.
Just a week before the pro football draft, Abbott held a high-profile draft day experience for our HeartMates program. Hosted by Abbott, professional football player and heart health advocate Damar Hamlin and Tedy Bruschi, a three-time pro league champion, Abbott HeartMates Draft Day recognized 11 people and their caregivers from across the United States who have come back from serious cardiovascular conditions and made them official members of the Abbott HeartMates team.
Hamlin and Bruschi know a thing or two about comebacks - as well as the importance of heart health and having support from a team. When Hamlin experienced a cardiac event during a game in 2023, his teammates, family and medical team had his back like true MVPs. And in 2005, Bruschi experienced a stroke caused by a hole in his heart. After receiving an Abbott Amplatzer device, he was able to rejoin his team just months later and was named the 2005 Comeback Player of the Year.
"Draft Day was one of the most exciting and memorable days of my life," Hamlin said. "Today I am inspired by the amazing bravery and resilience of each of the Abbott HeartMates and hope they feel just as I did on the day I was drafted."
"Anyone can be impacted by a heart condition," Bruschi said. "That's why it is so important to not only raise awareness about the signs and symptoms of heart disease, stroke and other ailments, but also share diverse stories of survivor comeback journeys."
The celebration kicked off at the New York Stock Exchange, where draftees joined Hamlin and cardiovascular experts from Abbott on the trading-floor podium to ring the iconic opening bell. Later in the day, HeartMates and their guests, along with Abbott employees and media, gathered at a special venue for a one-of-a-kind event that captured the excitement and ceremony of a professional sports draft.
Hamlin and Bruschi introduced each Heartmate from the stage, telling the story of how they discovered their heart condition and what it took for them to make their comeback. In practically every case, the support and sense of community each person received from their team of family members, friends and medical professionals were significant factors in spurring their recovery.
After being recognized onstage, each HeartMate received a personalized team jersey and signed a contract in which they committed to inspiring others with their stories.
"Our HeartMates reflect a broad scope of the population impacted by cardio conditions," said Nadim Geloo, M.D., senior director of medical affairs in Abbott's Structural Heart business. "We have HeartMates who are experiencing heart failure and are on the list to receive a heart transplant, those who were born with holes in their hearts that didn't close on the own, and people from many backgrounds and age ranges. Their stories offer hope and solidarity to so many people around the country and the world."
The inaugural Abbott HeartMates team includes the following heart-health champions.
Michael Brafi, a college football player from Woodbury, N.Y., experienced sudden cardiac arrest similar to Hamlin but caused by a previously undiagnosed heart defect. Brafi met Hamlin at a HeartMates event at his hospital, and the two bonded over their shared experience.
Lakeisha Brown, a wife and mother of four daughters and owner of a catering business in Houston, started experiencing discomfort in her chest in 2018. After seeing several doctors and receiving a pacemaker defibrillator, her condition continued to deteriorate into heart failure. Brown received a HeartMate 3 Left Ventricular Assist Device (LVAD) and is now back to living her life to the fullest.
Tony Daly, aka "Little Tony," lives in Las Vegas. As a premature infant born at 26 weeks and six days, he was the first person to receive Abbott's Amplatzer Piccolo Occluder to close a hole in his heart. Thanks to this life-saving procedure, Daly is now thriving and loves tennis, soccer and excels at school.
Chris Donges of Wilmington, Del., experienced heart failure when he was 30 years old. After a prolonged hospital stay that included a medically induced coma, he received a HeartMate 3 LVAD. Donges will be marrying his long-time fiancé Meghan in October, whom he was dating at the time, and the couple has two young children.
Brody Lambert, a father of four with his own construction company and a small farm in Provo, Utah, has overcome several conditions, undergone a heart transplant and has a HeartMate II LVAD. Most recently, Lambert was enrolled in the clinical trial for the TriClip G4 system, Abbott's minimally invasive device for repairing leaky tricuspid valves, which was approved by the FDA in early April.
MacKenzie Maddry has overcome a lot in her 17 years. Diagnosed with osteosarcoma at age 14, Maddry underwent 21 cycles of chemotherapy. This intense treatment, coupled with multiple surgeries and infections, put her cancer in remission but led to heart failure. Maddry received a HeartMate 3 LVAD device in 2022 and was the first pediatric patient discharged from her hospital with an LVAD. She has since returned to her high school studies in Bella Vista, Ark., had another leg reconstruction surgery and is looking forward to being listed for a heart transplant.
Ezekiel "Zeke" Mankins was first Abbott HeartMates draftee and was featured on NBC Nightly News. At age 12 Mankins had open heart surgery and received an Abbott Masters mechanical heart valve to repair a leaking mitral valve, and he's now a star on his high school track team in Midlothian, Texas. He is also an accomplished trombonist and aspiring pilot.
Alicia Nicoletti was in a car accident at age 22 that severely injured her heart and eventually lead to heart failure. In 2021, Nicoletti was implanted with the CardioMEMS HF System that allows her medical team to remotely monitor her pulmonary artery pressure and intervene if necessary. Now almost 20 years after her accident, Nicoletti is living in Wantagh, N.Y., successfully managing her heart failure and educating others about the condition.
Karen Pekowitz is a mother and teacher from Wellesley, Mass., who received her first pacemaker when she was just 19 years old. Earlier this year she became the first person in Massachusetts to receive an AVEIR DR, the world's first dual chamber leadless pacemaker system.
Leonardo Rodriguez grew up in New York City and enjoyed all it had to offer - but not always with heart health in mind. Rodriguez developed heart disease in his early 50s and received his first stent at age 54. Taking his doctor's advice to heart, he immediately adopted healthier habits and has a new lease on life.
Seth Wharton of LaVale, Md., had his first heart surgery, necessary to treat his severe aortic stenosis, when he was just 1 month old. After a battery of additional operations and treatments, Wharton went on to become a college basketball player, a father of four and a Guinness World Record holder for the longest survivor of an artificial double heart valve replacement - both of which were Abbott valves.
About Abbott HeartMates
The Abbott HeartMates program celebrates the bravery in those with cardiovascular conditions, the teams of families, friends and caregivers who support them, and the heroes providing the medical care need to help people make their comeback. By creating a community in which members can share stories, connect with others going through similar heart-health journeys and receive emotional support, Abbott and program ambassador Damar Hamlin hope to inspire people and ensure that no one faces these health challenges alone. Rounding out the team is a lineup of Abbott cardio experts to provide knowledge and resources in language that's easy to understand.
Throughout the year, Hamlin and Abbott will visit hospitals around the country to recruit new HeartMates, host virtual huddles and share exclusive content that's only available to teammates.
For more information about HeartMates, visit HeartMates.Abbott.
IMPORTANT SAFETY INFORMATION
CARDIOMEMS™ HF SYSTEM
AVEIR™ DR
AMPLATZER PICCOLOTM OCCLUDER
Rx Only
The Amplatzer Piccolo™ Occluder is a percutaneous, transcatheter occlusion device intended for the nonsurgical closure of a patent ductus arteriosus (PDA).
CONTRAINDICATIONS
Weight < 700 grams at time of the procedure; Age < 3 days at time of procedure; Coarctation of the aorta; Left pulmonary artery stenosis; Cardiac output that is dependent on right to left shunt through the PDA due to pulmonary hypertension; Intracardiac thrombus that may interfere with the implant procedure; Active infection requiring treatment at the time of implant; Patients with a PDA length smaller than 3 mm; Patients with a PDA diameter that is greater than 4 mm at the narrowest portion.
POTENTIAL ADVERSE EVENTS
Potential adverse events that may occur during or after a procedure using this device may include, but are not limited to: Air embolus, Allergic reaction, Anemia, Anesthesia reactions, Apnea, Arrhythmia, Bleeding, Cardiac perforation, Cardiac tamponade, Chest pain, Device embolization, Device erosion, Death, Endocarditis, Fever, Headache/migraine, Hemolysis, Hematoma, Hypertension, Hypotension, Infection, Myocardial infarction, Palpitations, Partial obstruction of aorta, Partial obstruction of pulmonary artery, Pericardial effusion, Pericarditis, Peripheral embolism, Pleural effusion, Pulmonary embolism, Re-intervention for device removal, Respiratory distress, Stroke, Thrombus, Transient ischemic attack, Valvular regurgitation, Vascular access site injury, Vascular occlusion, Vessel perforation.
HEARTMATE 3
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 HeartMate 3 Left Ventricular Assist System is indicated for providing short- and long-term mechanical circulatory support (e.g., as bridge to transplant or myocardial recovery, or destination therapy) in adult and pediatric patients with advanced refractory left ventricular heart failure and with an appropriate body surface area.
Contraindications: The HeartMate 3 Left Ventricular Assist System is contraindicated for patients who cannot tolerate, or who are allergic to, anticoagulation therapy.
Adverse Events: Adverse events that may be associated with the use of the HeartMate 3™ Left Ventricular Assist System are: death, bleeding, cardiac arrhythmia, localized infection, right heart failure, respiratory failure, device malfunctions, driveline infection, renal dysfunction, sepsis, stroke, other neurological event (not stroke-related), hepatic dysfunction, psychiatric episode, venous thromboembolism, hypertension, arterial non-central nervous system (CNS) thromboembolism, pericardial fluid collection, pump pocket or pseudo pocket infection, myocardial infarction, wound dehiscence, hemolysis (not associated with suspected device thrombosis) or pump thrombosis.
HEARTMATE II LVAD
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 HeartMate II™ Left Ventricular Assist System is indicated for use as a "bridge to transplantation" for cardiac transplant candidates who are at risk of imminent death from non-reversible left ventricle failure. It is also indicated for use in patients with New York Heart Association (NYHA) Class IIIB or IV end-stage left ventricular failure, who have received optimal medical therapy for at least 45 of the last 60 days, and who are not candidates for cardiac transplantation. The HeartMate II Left Ventricular Assist System is intended for use both inside and outside of the hospital, or for transportation of Left Ventricular Assist Device patients via ground ambulance, airplane, or helicopter.
Contraindications: The HeartMate II Left Ventricular Assist System is contraindicated for patients who cannot tolerate, or who are allergic to, anticoagulationtherapy.
Adverse Events: Adverse events that may be associated with the use of the HeartMate II Left Ventricular Assist System are listed below. Adverse events are listed in decreasing order of frequency, except for death, which appears first because it is a non-reversible complication:Death, Bleeding (perioperative or late), Cardiac arrhythmia, Local infection, Respiratory failure, Device malfunction, Sepsis, Right heart failure, Driveline or pump pocket infection, Renal failure, Stroke, Neurologic dysfunction, Psychiatric episode, Peripheral thromboembolic event, Hemolysis, Hepatic dysfunction, Device thrombosis, Myocardial infarction.
TRICLIP™ G4 SYSTEM
Rx Only
INDICATIONS
The TriClip™ G4 System is indicated for improving quality of life and functional status in patients with symptomatic severe tricuspid regurgitation despite optimal medical therapy, who are at intermediate or greater risk for surgery and in whom transcatheter edge-to-edge valve repair is clinically appropriate and is expected to reduce tricuspid regurgitation severity to moderate or less, as determined by a multidisciplinary heart team.
CONTRAINDICATIONS
The TriClip G4 System is contraindicated in patients with the following conditions: Intolerance, including allergy or untreatable hypersensitivity, to procedural anticoagulation; Untreatable hypersensitivity to implant components (nickel-titanium alloy, cobalt-chromium alloy); Active endocarditis or other active infection of the tricuspid valve. POTENTIAL
ADVERSE EVENTS
The following events have been identified as possible complications of the TriClip™ G4 Procedure. Allergic reactions or hypersensitivity to latex, contrast agent, anaesthesia, device materials and drug reactions to anticoagulation, or antiplatelet drugs; Additional treatment / surgery from device-related complications; Bleeding; Blood disorders (including coagulopathy, hemolysis, and Heparin Induced Thrombocytopenia (HIT)); Cardiac arrhythmias (including conduction disorders, atrial arrhythmias, ventricular arrhythmias); Cardiac ischemic conditions (including myocardial infarction, myocardial ischemia, and unstable / stable angina); Cardiac perforation; Cardiac tamponade; Chest pain; Death; Dyspnea; Edema; Embolization (device or components of the device); Endocarditis; Fever or hyperthermia; Fluoroscopy, Transesophageal echocardiogram (TEE) and Transthoracic echocardiogram (TTE) -related complications: Skin injury or tissue changes due to exposure to ionizing radiation, Esophageal irritation, Esophageal perforation, Gastrointestinal bleeding; Hypotension / hypertension; Infection including: Septicemia; Nausea / vomiting; Pain; Pericardial effusion; Stroke / Cerebrovascular accident (CVA) and Transient Ischemic Attack (TIA); System organ failure: Cardio-respiratory arrest, Worsening heart failure, Pulmonary congestion, Respiratory dysfunction / failure / atelectasis, Renal insufficiency or failure, Shock (including cardiogenic and anaphylactic); Thrombosis; Tricuspid valve complications, which may complicate or prevent later surgical repair, including: Chordal entanglement / rupture, Single Leaflet Device Attachment (SLDA), Dislodgement of previously implanted devices, Tissue damage, Tricuspid valve stenosis, Worsening, Persistent or residual regurgitation; Vascular access complications which may require additional intervention, including: Wound dehiscence, Bleeding of the access site, Arteriovenous fistula, pseudoaneurysm, aneurysm, dissection, perforation / rupture, vascular occlusion, Embolism (air, thrombus), Peripheral nerve injury; Venous thromboembolism (including deep vein thrombosis, pulmonary embolism). CAUTION: Product(s) intended for use by or under the direction of a physician. Prior to use, reference to the Instructions for Use, inside the product carton (when available) or at https://www.eifu.abbott/ for more detailed information on Indications, Contraindications, Warnings, Precautions and Adverse Events.
MASTERS SERIES MECHANICAL HEART VALVE
Rx Only
Indications for Use
The SJM™ Masters Series Mechanical Heart Valve is intended for use as a replacement valve in patients with a diseased, damaged, or malfunctioning aortic or mitral heart valve. This device may also be used to replace a previously implanted mitral or aortic prosthetic valve.
Contraindications
The SJM™ Masters Series Mechanical Heart Valve is contraindicated for individuals unable to tolerate anticoagulation therapy.
Potential Adverse Events
Complications associated with replacement mechanical heart valves include, but are not limited to, hemolysis, infections, thrombus, or thromboembolism, valve dehiscence, unacceptable hemodynamic performance, hemorrhagic complications secondary to anticoagulation therapy, prosthetic failure, failure or death. Any of these complications may require reoperation or explantation of the device.
CARDIOMEMS™ HF SYSTEM
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.
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.
CardioMEMS HF System 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 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 acknowledgement 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.
AVEIR™ DR
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 management of one or more of the following permanent conditions: Syncope, Pre-syncope, Fatigue, Disorientation. Rate-modulated pacing is indicated for patients with chronotropic incompetence, and for those who would benefit from increased stimulation rates concurrent with physical activity. Dual-chamber pacing is indicated for patients exhibiting: Sick sinus syndrome, Chronic, symptomatic second- and third-degree AV block, Recurrent Adams-Stokes syndrome, Symptomatic bilateral bundle-branch block when tachyarrhythmia and other causes have been ruled out. Atrial pacing is indicated for patients with: Sinus node dysfunction and normal AV and intraventricular conduction systems. Ventricular pacing is indicated for patients with: Significant bradycardia and normal sinus rhythm with only rare episodes of AV block or sinus arrest, Chronic atrial fibrillation, Severe physical disability.
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 and/or right atrium. The LP is intended to provide sensing of intrinsic cardiac signals and delivery of cardiac pacing therapy within the implanted chamber for the target treatment group. The LP is also intended to operate optionally with another co-implanted LP to provide dual-chamber pacing therapy.
The Aveir™ Delivery Catheter 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 the Product Materials section of the 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 or dual 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, contrast media, 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.
MAT-2306873 v1.0 | Item is approved for US Use
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SOURCE: Abbott
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