Amulet Brings Competition to Key Device Market

Data show Abbott's device has superior LAA closure compared to the other minimally invasive product in this market. 

Amulet Brings Competition to Key Device Market
Strategy and Strength | Aug. 30, 2021

Abbott has an exciting structural heart portfolio opportunity with the U.S. Food and Drug Administration approval of its minimally invasive Amplatzer Amulet Left Atrial Appendage (LAA) Occluder for people with atrial fibrillation (AFib).

Amulet, which closes the left atrial appendage (a small pouch connected to the heart's upper left chamber) to help prevent blood clots and reduce stroke risk in people with AFib, brings competition to the $500 million U.S. LAA market,1 which — up until now — has been a single-product market.

Adding to Abbott's momentum are new data that show Amulet has superior closure and noninferior safety and effectiveness in LAA closure to the other device on the market. The findings come from a much-anticipated, head-to-head study comparing Amulet with the competitor product.

Abbott's Amulet — already a market leader in Europe, the Middle East and Asia — stands out from the competition with its dual-seal technology, completely and immediately sealing the LAA to help prevent blood clots from traveling to the brain and causing a stroke. Thanks to the dual seal, people with Amulet don't need to use blood-thinning medication (which can increase risk of major bleeding) once they've had the procedure.

In addition to providing much-needed treatment options, as the nation's aging population contributes to a rise in AFib cases (up to 6 million people in the U.S. have the condition, surging to potentially 16 million by 2050),2 the FDA approval of Amulet also boosts Abbott's structural heart portfolio — the broadest in the U.S.3 — and is expected to expand the company's user base.

"We believe Amulet will become a needle-moving product that will help sustain the elite high-single-digit organic revenue growth profile of the Medical Devices business," wrote Cowen analysts in a recent report.1

Breadth of Portfolio
Structural heart conditions refer to defects or abnormalities in the heart's valves, walls and/or muscle. These heart problems affect tens of millions of people worldwide, and that number's projected to grow with the aging population.

Abbott's Structural Heart business contributes more than a billion dollars in sales every year, highlighting the company's strength in the market as well as its potential to expand.

Expected to help sustain the portfolio's momentum is Abbott's robust pipeline, including valve solutions Tendyne* and TriClip,** along with the company's market-leading MitraClip device.

"The FDA's approval of Amulet is a significant milestone in allowing us to bring this therapy to American physicians and patients, and improves upon the currently available treatment option to provide people even greater peace of mind against stroke risk," said Michael Dale, senior vice president of Abbott's Structural Heart business.

"We've been marching toward this moment since forming our dedicated structural heart division and our Amulet device makes an important addition to our portfolio."

Learn more about Amulet and the latest data.

*The Tendyne Transcatheter Mitral Valve Implantation System is an investigational device only in the U.S.
**The TriClip Transcatheter Tricuspid Valve Repair System is an investigational device only in the U.S.

References
1Cowen, Ahead of the Curve Series: ABT to Join BSX in the U.S. Market for Left Atrial Appendage Closure, June 30, 2021.
2Circulation Research, Kornej et al., "Epidemiology of Atrial Fibrillation in the 21st Century," June 18, 2020
3Internal data at Abbott.

This story was originally published on August 17, 2021. It was updated on August 30, 2021 to reflect the announcement of new data.

IMPORTANT SAFETY INFORMATION

MitraClip System

AMULET

The Amplatzer™ Amulet™ Left Atrial Appendage Occluder is a percutaneous transcatheter device intended to reduce the risk of thrombus embolization from the left atrial appendage (LAA) in patients who have nonvalvular atrial fibrillation and who are at increased risk for stroke and systemic embolism based on CHADS2 or CHA2DS2-VASc scores, are suitable for short term anticoagulation therapy, and have appropriate rationale to seek a non-pharmacologic alternative to oral anticoagulation, taking into consideration the safety and effectiveness of the device.

CAUTION: This product is intended for use by or under the direction of a physician. Prior to use, reference the Instructions for Use, inside the product carton (when available) or at eifu.abbottvascular.com or at Medical.abbott/manuals for more detailed information on Indications, Contraindications, Warnings, Precautions and Adverse Events.

CONTRAINDICATIONS
The Amplatzer™ Amulet™ Left Atrial Appendage (LAA) Occluder is contraindicated for patients:

  • with the presence of intracardiac thrombus,
  • with active endocarditis or other infections producing bacteremia.
  • where placement of the device would interfere with any intracardiac or intravascular structures.
     

WARNINGS

  • If the device is retracted farther than the radiopaque markers (fully recaptured), the device and the sheath must both be removed and replaced. Failure to replace both the device and the sheath may result in sheath and/or device malfunction.
  • Physicians must be prepared to deal with urgent situations, such as pericardial effusion or device embolization, which can require removal of the device.
  • This device should be used only by physicians who are trained in standard transcatheter techniques. The physician should determine which patients are candidates for procedures that use this device.
  • Late pericardial effusion events were observed in the clinical study. The use of post-procedure anticoagulation therapy may be associated with an increased potential for a late pericardial effusion. Physicians should monitor for signs and symptoms of pericardial effusion and obtain appropriate imaging when indicated. Physicians should also consider routine echocardiography to screen for pericardial effusion.
  • Remove embolized devices. Do not remove an embolized device unless the device is fully captured inside a sheath.

IMPORTANT SAFETY INFORMATION
The Amplatzer™ Amulet™ device contains a nickeltitanium alloy, which is generally considered safe. However, in vitro testing has demonstrated that nickel is released from this device for a minimum of 120 days. Patients who are allergic to nickel may have an allergic reaction to this device, especially those with a history of metal allergies. Certain allergic reactions can be serious; patients should be instructed to seek medical assistance immediately if they suspect they are experiencing an allergic reaction. Symptoms may include difficulty in breathing or swelling of the face or throat. While data are currently limited, it is possible that some patients may develop an allergy to nickel if this device is implanted.

  • Do not use this device if the sterile package is open or damaged.
  • The device was sterilized with ethylene oxide and is for single use only. Do not reuse or resterilize this device. Attempts to resterilize this device can cause a malfunction, insufficient sterilization, or harm to the patient.
  • Use on or before the expiration date that is printed on the product packaging label.

PRECAUTIONS

  • The physician should exercise clinical judgment in situations that involve the use of antithrombotic drugs before, during, and/or after the use of this device.
  • The physician should exercise caution if implanting a device in a patient who has an implantable cardioverter defibrillator (ICD) or pacemaker leads.
  • The physician should have the guidewire in the left upper pulmonary vein when making exchanges in the left atrium.
  • Ensure that the vasculature is adequate for the sheath size being selected.
  • The physician should exercise caution if performing ablation at or near the implant site after the device is implanted.
  • Use standard interventional cardiovascular catheterization techniques when using Amplatzer™ products.
  • Use in specific populations
    - Pregnancy – Minimize the radiation exposure to the fetus and the mother.
    - Nursing mothers – There has been no quantitative assessment for the presence of leachables in breast milk.

MRI SAFETY INFORMATION
Non-clinical testing has demonstrated that the Amplatzer™ Amulet™ Left Atrial Appendage Occluder device is MR Conditional. A patient with the Amplatzer™Amulet™ device can be safely scanned in an MR system under the following conditions:

  • Static magnetic fields of 1.5 Tesla (1.5T) and 3.0 Tesla (3.0T)
  • Maximum spatial gradient field of 19 T/m (1900 G/cm)
  • Maximum MR system reported, whole-body averaged specific absorption rate (SAR) of 2.0 W/kg (normal operating mode)

Under the scan conditions defined above, the device is expected to produce a maximum temperature rise of less than or equal to 4°C after 15 minutes of continuous scanning.

In non-clinical testing, the image artifact caused by the device extends radially up to 20 mm from the device when imaged with a gradient echo pulse sequence in a 3.0T MR system.

POTENTIAL ADVERSE EVENTS
Potential adverse events associated with the device or implant procedure include, but are not limited to, the following:

  • Air embolism
  • Airway trauma
  • Allergic reaction
  • Anemia
  • Anesthesia reaction (nausea, vasovagal reaction, confusion/altered mental status or other)
  • Arrhythmia
  • Atrial septal defect
  • Bleeding
  • Cardiac arrest
  • Cardiac tamponade
  • Chest pain/discomfort
  • Congestive heart failure
  • Death
  • Device embolization
  • Device erosion
  • Device malfunction
  • Device malposition
  • Device migration
  • Device-related thrombus
  • Fever
  • Hematuria
  • Hypertension/hypotension
  • Infection
  • Multi-organ failure
  • Myocardial infarction
  • Perforation
  • Pericardial effusion
  • Pleural effusion
  • Renal failure/dysfunction
  • Respiratory failure
  • Seizure
  • Significant residual flow
  • Stroke
  • Thrombocytopenia
  • Thromboembolism: peripheral and pulmonary
  • Thrombus formation
  • Transient ischemic attack
  • Valvular regurgitation/insufficiency
  • Vascular access site injury (hematoma, pseudoaneurysm, arteriovenous fistula, groin pain or other)
  • Vessel trauma/injury

CAUTION: This product is intended for use by or under the direction of a physician. Prior to use, reference the Instructions for Use, inside the product carton (when available) or at eifu.abbottvascular.com or at medical.abbott/manuals for more detailed information on Indications, Contraindications, Warnings, Precautions and Adverse Events.

MitraClip System

INDICATION FOR USE • The MitraClipTM G4 System is indicated for the percutaneous reduction of significant symptomatic mitral regurgitation (MR ≥ 3+) due to primary abnormality of the mitral apparatus [degenerative MR] in patients who have been determined to be at prohibitive risk for mitral valve surgery by a heart team, which includes a cardiac surgeon experienced in mitral valve surgery and a cardiologist experienced in mitral valve disease, and in whom existing comorbidities would not preclude the expected benefit from reduction of the mitral regurgitation. • The MitraClipTM G4 System, when used with maximally tolerated guideline-directed medical therapy (GDMT), is indicated for the treatment of symptomatic, moderate to-severe or severe secondary (or functional) mitral regurgitation (MR; MR ≥ Grade III per American Society of Echocardiography criteria) in patients with a left ventricular ejection fraction (LVEF) ≥ 20% and ≤ 50%, and a left ventricular end systolic dimension (LVESD) ≤ 70 mm whose symptoms and MR severity persist despite maximally tolerated GDMT as determined by a multidisciplinary heart team experienced in the evaluation and treatment of heart failure and mitral valve disease. CONTRAINDICATIONS The MitraClipTM G4 System is contraindicated in patients with the following conditions: • Patients who cannot tolerate, including allergy or hypersensitivity to, procedural anticoagulation or post procedural anti-platelet regimen • Patients with known hypersensitivity to clip components (nickel / titanium, cobalt, chromium, polyester), or with contrast sensitivity • Active endocarditis of the mitral valve • Rheumatic mitral valve disease • Evidence of intracardiac, inferior vena cava (IVC) or femoral venous thrombus WARNINGS • DO NOT use MitraClipTM outside of the labeled indication. • The MitraClipTM G4 Implant should be implanted with sterile techniques using fluoroscopy and echocardiography (e.g. transesophageal [TEE] and transthoracic [TTE]) in a facility with on-site cardiac surgery and immediate access to a cardiac operating room. • Read all instructions carefully. Use universal precautions for biohazards and sharps while handling the MitraClipTM G4 System to avoid user injury. Failure to follow these instructions, warnings and precautions may lead to device damage, user injury or patient injury including: n MitraClipTM G4 Implant erosion, migration or malposition n Failure to deliver MitraClipTM G4 Implant to the intended site n Difficulty or failure to retrieve MitraClipTM G4 system components • Use caution when treating patients with hemodynamic instability requiring inotropic support or mechanical heart assistance due to the increased risk of mortality in this patient population. The safety and effectiveness of MitraClipTM in these patients has not been evaluated. • Patients with a rotated heart due to prior cardiac surgery in whom the System is used may have a potential risk of experiencing adverse events such as atrial perforation, cardiac tamponade, tissue damage, and embolism which may be avoided with preoperative evaluation and proper device usage. • For the Steerable Guide Catheter and Delivery Catheter only: n The Guide Catheter: the distal 65 cm of the Steerable Guide Catheter with the exception of the distal soft tip, is coated with a hydrophilic coating. n The Delivery Catheter: coated with a hydrophilic coating for a length of approximately 131 cm. n Failure to prepare the device as stated in these instructions and failure to handle the device with care could lead to additional intervention or serious adverse event. • The Clip Delivery System is provided sterile and designed for single use only. Cleaning, re-sterilization and / or reuse may result in infections, malfunction of the device and other serious injury or death. • Note the product “Use by” date specified on the package. • Inspect all product prior to use. Do not use if the package is open or damaged, or if product is damaged. PRECAUTIONS • Prohibitive Risk Primary (or degenerative) Mitral Regurgitation n Prohibitive risk is determined by the clinical judgment of a heart team, including a cardiac surgeon experienced in mitral valve surgery and a cardiologist experienced in mitral valve disease, due to the presence of one or more of the following documented surgical risk factors: ◆ 30-day STS predicted operative mortality risk score of 4 ≥8% for patients deemed likely to undergo mitral valve replacement or 4 ≥6% for patients deemed likely to undergo mitral valve repair n Porcelain aorta or extensively calcified ascending aorta. n Frailty (assessed by in-person cardiac surgeon consultation) n Hostile chest n Severe liver disease / cirrhosis (MELD Score > 12) n Severe pulmonary hypertension (systolic pulmonary artery pressure > 2/3 systemic pressure) n Unusual extenuating circumstance, such as right ventricular dysfunction with severe tricuspid regurgitation, chemotherapy for malignancy, major bleeding diathesis, immobility, AIDS, severe dementia, high risk of aspiration, internal mammary artery (IMA) at high risk of injury, etc. n Evaluable data regarding safety or effectiveness is not available for prohibitive risk Primary patients with an LVEF < 20% or an LVESD > 60 mm. MitraClipTM should be used only when criteria for clip suitability for Primary have been met. n The heart team should include a cardiac surgeon experienced in mitral valve surgery and a cardiologist experienced in mitral valve disease and may also include appropriate physicians to assess the adequacy of heart failure treatment and valvular anatomy. • Secondary Mitral Regurgitation n Evaluable data regarding safety or effectiveness is not available for secondary MR patients with an LVEF < 20% or an LVESD > 70 mm. n The multidisciplinary heart team should be experienced in the evaluation and treatment of heart failure and mitral valve disease and determine that symptoms and MR severity persist despite maximally tolerated GDMT. POTENTIAL COMPLICATIONS AND ADVERSE EVENTS The following ANTICIPATED EVENTS have been identified as possible complications of the MitraClipTM G4 procedure. • Allergic reactions or hypersensitivity to latex, contrast agent, anaesthesia, device materials (nickel / titanium, cobalt, chromium, polyester), and drug reactions to anticoagulation, or antiplatelet drugs • Vascular access complications which may require transfusion or vessel repair including: n wound dehiscence n catheter site reactions n Bleeding (including ecchymosis, oozing, hematoma, hemorrhage, retroperitoneal hemorrhage) n Arteriovenous fistula, pseudoaneurysm, aneurysm, dissection, perforation / rupture, vascular occlusion n Emboli (air thrombotic material, implant, device component) n Peripheral Nerve Injury • Lymphatic complications • Pericardial complications which may require additional intervention, including: n Pericardial effusion n Cardiac tamponade n Pericarditis • Cardiac complications which may require additional interventions or emergency cardiac surgery, including: n Cardiac perforation n Atrial septal defect • Mitral valve complications, which may complicate or prevent later surgical repair, including: n Chordal entanglement / rupture n Single Leaflet Device Attachment (SLDA) n Thrombosis n Dislodgement of previously implanted devices n Tissue damage n Mitral valve stenosis n Persistent or residual mitral regurgitation n Endocarditis • Cardiac arrhythmias (including conduction disorders, atrial arrhythmias, ventricular arrhythmias) • Cardiac ischemic conditions (including myocardial infarction, myocardial ischemia, and unstable / stable angina) • Venous thromboembolism (including deep vein thrombosis, pulmonary embolism, post procedure pulmonary embolism) • Stroke / Cerebrovascular accident (CVA) and Transient Ischemic Attack (TIA) • System organ failure: n Cardio-respiratory arrest n Worsening heart failure n Pulmonary congestion n Respiratory dysfunction / failure / atelectasis n Renal insufficiency or failure n Shock (including cardiogenic and anaphylactic) • Blood cell disorders (including coagulopathy, hemolysis, and Heparin Induced Thrombocytopenia (HIT)) • Hypotension / hypertension • Infection including: n Urinary Tract Infection (UTI) n Pneumonia n Septicemia • Nausea / vomiting • Chest pain • Dyspnea • Edema • Fever or hyperthermia • Pain • Death • Fluoroscopy, Transesophageal echocardiogram (TEE) and Transthoracic echocardiogram (TTE) -related complications: n Skin injury or tissue changes due to exposure to ionizing radiation n Esophageal irritation n Esophageal perforation n Gastrointestinal bleeding. Caution: This product is intended for use by or under the direction of a physician. Prior to use, reference the Instructions for Use provided inside the product carton (when available) or at eifu.abbottvascular.com or at medical.abbott/manuals for more detailed information on Indications, Contraindications, Warnings, Precautions and Adverse Events. TM Indicates a trademark of the Abbott Group of Companies. www.Cardiovascular.Abbott

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