POV:
Your legs feel like they’re in quicksand.
You’re exhausted and can’t get out of bed.
You want to eat but have no appetite.
This is reality for many of the 1.6 million people in the U.S. living with one of the most common conditions you’ve never heard of — tricuspid regurgitation (TR) — which is otherwise known as a leaky heart valve.
The tricuspid valve is crucial, allowing blood to move from the heart to the lungs. And if the tricuspid valve doesn’t seal fully when it closes and has a leak, some of the blood will flow backward within the heart, instead of moving forward to the lungs. This can force the heart to work harder, causing a range of negative effects.
The result: for many, everything from movement issues to a lack of energy to the inability to live their lives with the freedom and quality they deserve. It can mean missing out on memory-making and time spent with loved ones.
TR has taken too much from too many and left them with limited options.
For some with TR, symptoms persist despite medical therapy, and open-heart surgery isn’t even feasible. People from caregivers to researchers to those living with the condition searched for a minimally invasive treatment that could be an option for those not considered good candidates for surgery. We were up for the challenge.
The first-of-its-kind TriClip G4 system — designed to repair a leaky tricuspid valve — is helping to offer improved quality of life in a tiny device. And it’s now approved for select TR patients by the FDA.
The introduction of the TriClip G4 system in the U.S. opens new avenues for some of the people living with TR who otherwise would remain untreated.
But a challenge it was.
In creating our MitraClip system, we saw what was possible in repairing the mitral valve. We knew that a similar solution for TR could help the millions of people living with the condition globally, but TR was more complicated to treat.
Santosh Prabhu, our divisional vice president of product development in Abbott’s Structural Heart business, described the intricacies of developing a solution for what is often referred to as the “forgotten valve.”
“A minimally invasive way to treat tricuspid regurgitation was an unmet clinical need. We wanted to develop a product that would allow physicians to treat tricuspid regurgitation in an easy, safe and effective manner,” he said. “And much of this work of developing the TriClip system was done in close collaboration with physicians.”
From understanding the anatomy of the tricuspid valve to designing the delivery system to building simulators to evaluate the product concepts, the team conducted extensive research to develop the best solution for treating TR. That became the TriClip system — a product that has made the tricuspid valve no longer so forgotten.
All of this, and yet people who undergo the procedure typically only need a short recovery afterward.
“Years ago, with advanced tricuspid regurgitation, you were looking at a potentially risky surgery and staring down the path of poor quality of life and life expectancy,” Prabhu explained. “Now, with the introduction of TriClip, people are feeling better, short- and long-term.”
Decades of work to create systems that can help repair these critical areas of the heart, all leading to the potential for less discomfort and physical limitations — and more life for millions.
Now, their POV is much more hopeful.
Important safety information
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.
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