Max Page, a 12-year old actor known for his role in a Super Bowl commercial, receives a heart valve that – not too long ago – was just science fiction.
Tough. Painful. And six months long.
That’s the only way Jennifer Page describes the open-heart surgery her son Max endured when he was 7-years old.
“They crack your chest open and it takes months to heal,” she recalls. “It’s excruciating to watch.”
The surgery was needed to treat a heart condition Max was diagnosed with as a baby. Doctors implanted a pacemaker and an artificial heart valve.
Max remembers asking his mother if he would live through the procedure.
“There’s so much more I wanted to do in life,” he said. “And it was scary.”
Max recovered from the surgery and returned to golf, baseball, and hanging around with his younger brother. And today, while Max appears to be an average kid, he’s grown up in front of the camera and been seen by millions. As a child actor, he’s had roles in several projects including a starring role as a mini Darth Vader in a 2011 Super Bowl commercial for Volkswagen.
“I had no idea how big that commercial would be,” he laughs. “It was an honor to be a part of it.”
But studio lights were replaced by operating room lights following Max’s tenth birthday. Doctors needed to replace the heart valve they had implanted three years earlier. The anticipation of a long, painful recovery for Max loomed again over the Page family. This time, however, there was another option.
Not sure where my path will take me. But I’m ready for it.Max Page, 12
Physicians — instead — implanted the MelodyTM Transcatheter Pulmonary Valve (TPV). Using a minimally invasive procedure, the valve is inserted by a catheter through a tiny opening near the groin. The heart valve passes through the femoral vein all the way to the heart where surgeons use a balloon-like device to expand the valve into place.
“The Melody TPV works well for patients of all age groups,” says Medtronic R&D leader Anil Mankodi. “Patients born with complex congenital heart defects will likely need multiple procedures throughout their life span, more so in the early stages. The Melody valve offers sizing flexibility with excellent performance.”
Currently, many patients receiving the Melody TPV are younger than 21-years old.
“This innovation addresses the needs of patients born with congenital heart disease who will require a lifetime of care,” says Mankodi. “As such, our commitment to finding more options for them is fully aligned with the Medtronic Mission to alleviate pain, restore health and extend life.”
For Max, his second valve replacement was much different than the first.
“Recovery didn’t take six months. It felt more like six hours,” says Jennifer. “Compare that to his previous open heart surgeries and we feel very blessed.”
Max knows he will require more surgeries, interventions and doctor appointments. But knowing this, he plans to be an advocate for other children living with heart disease.
And that – the young actor says - might be his most important role.
“Not sure where my path will take me,” he says. “But I’m ready for it.”
Melody™Transcatheter Pulmonary Valve, Ensemble™ II Transcatheter Valve Delivery System
Important Labeling Information for the United States
Indications: The Melody TPV is indicated for use in the management of pediatric and adult patients who have a clinical indication for intervention on a dysfunctional right ventricular outflow tract (RVOT) conduit or surgical bioprosthetic pulmonary valve that has ≥ moderate regurgitation, and/or a mean RVOT gradient ≥35 mm Hg.
Contraindications: None known.
• DO NOT implant in the aortic or mitral position. Pre-clinical bench testing of the Melody valve suggests that valve function and durability will be extremely limited when used in these locations.
• DO NOT use if patient’s anatomy precludes introduction of the valve, if the venous anatomy cannot accommodate a 22 Fr size introducer, or if there is significant obstruction of the central veins.
• DO NOT use if there are clinical or biological signs of infection including active endocarditis. Standard medical and surgical care should be strongly considered in these circumstances.
• Assessment of the coronary artery anatomy for the risk of coronary artery compression should be performed in all patients prior to deployment of the TPV.
• To minimize the risk of conduit rupture, do not use a balloon with a diameter greater than 110% of the nominal diameter (original implant size) of the conduit for pre-dilation of the intended site of deployment, or for deployment of the TPV.
• The potential for stent fracture should be considered in all patients who undergo TPV placement. Radiographic assessment of the stent with chest radiography or fluoroscopy should be included in the routine postoperative evaluation of patients who receive a TPV.
• If a stent fracture is detected, continued monitoring of the stent should be performed in conjunction with clinically appropriate hemodynamic assessment. In patients with stent fracture and significant associated RVOT obstruction or regurgitation, reintervention should be considered in accordance with usual clinical practice.
Potential procedural complications that may result from implantation of the Melody device include the following: rupture of the RVOT conduit, compression of a coronary artery, perforation of a major blood vessel, embolization or migration of the device, perforation of a heart chamber, arrhythmias, allergic reaction to contrast media, cerebrovascular events (TIA, CVA), infection/sepsis, fever, hematoma, radiation-induced erythema, blistering, or peeling of skin, pain, swelling, or bruising at the catheterization site.
Potential device-related adverse events that may occur following device implantation include the following: stent fracture*, stent fracture resulting in recurrent obstruction, endocarditis, embolization or migration of the device, valvular dysfunction (stenosis or regurgitation), paravalvular leak, valvular thrombosis, pulmonary thromboembolism, hemolysis.
*The term “stent fracture” refers to the fracturing of the Melody TPV. However, in subjects with multiple stents in the RVOT it is difficult to definitively attribute stent fractures to the Melody frame versus another stent.
For additional information, please refer to the Instructions for Use provided with the product or available on http://manuals.medtronic.com.
CAUTION: Federal law (USA) restricts this device to sale by or on the order of a physician.