# data[].attributes.body
U.S. Food & Drug Administration (2020).

The Society of Thoracic Surgeons (2020).

American College of Cardiology (2018).

Edwards Lifescience.

# data[].attributes.body
Against all odds this technology appears to be safe and beneficial. In the beginning stages, this was only approved for high risk or inoperable patients based on their Society of Thoracic Surgeons (STS) risk profile because of the unknown. With recent approval for low to moderate risk patients there's controversy at proper patient selection in regards to longevity of this valve. It's imperative that each patient is screened by a qualified heart team including, a cardio thoracic surgeon (who has performed at least 100 surgical aortic valve replacements (SAVR) in a lifetime, or 50 SAVRs in two year period) and a cardiologist (who has performed 100 TAVRs with at least 50 as primary operator and 300 percutaneous coronary interventions (PCI) in a year).

# data[].attributes.body
Less invasive than traditional open heart surgery
Minimal downtime
Shorter length of stay
Option for High-Risk or Inoperable patients who otherwise would not be candidates for heart valve replacement

# data[].attributes.body
Activator: can make things happen
Adaptability: ability to stay productive when demands are high
Strategic: enables me to sort through the clutter and find the best route
Arranger: enjoy managing all of the variables
Achiever: take immense satisfaction in being busy & productive

# data[].attributes.body
https://youtu.be/2MwuZGBWMBE?enablejsapi=1

# data[].attributes.body
https://www.fda.gov/medical-devices/recently-approved-devices/edwards-sapien-3-transcatheter-heart-valve-system-and-edwards-sapien-3-ultra-transcatheter-heart

The Society of Thoracic Surgeons (2020). Report find TAVR dominant form of aortic valve replacement, outcomes steadily improving in the united states. https://www.sts.org/media/news-releases/report-finds-tavr-dominant-form-aortic-valve-replacement-outcomes-steadily-improving-united-states

American College of Cardiology (2018). Operator and institutional requirements for TAVR. https://www.acc.org/latest-in-cardiology/ten-points-to-remember/2018/07/18/08/56/2018-expert-consensus-systems-of-care-document-tavr
https://www.edwards.com/

# data[].attributes.attachment_link.readable_text
This is a brief overview of information related to FDA's approval to market this product. See the links below to the Summary of Safety and Effectiveness Data (SSED and product labeling for more complete information on this product, its indications for use, and the basis for FDA's approval.

Product Name: Edwards SAPIEN 3 Transcatheter Heart Valve System and Edwards SAPIEN 3 Ultra Transcatheter Heart Valve System
PMA Applicant: Edwards Lifesciences LLC
Address: One Edwards Way, Irvine, CA 92614
Approval Date: August 16, 2019
Approval Letter: Approval Order

What is it? The Edwards SAPIEN 3 Transcatheter Heart Valve (THV) System and Edwards SAPIEN 3 Ultra THV System each consists of a catheter-based artificial aortic heart valve and accessories used to implant the valve without open-heart surgery. The valve is made of cow tissue attached to a balloon-expandable, cobalt-chromium frame for support.

The Edwards SAPIEN 3 THV System and Edwards SAPIEN 3 Ultra THV System were previously approved for the treatment of severe aortic stenosis (a narrowing of the aortic valve that restricts blood flow to aorta, the body's main artery) in patients at intermediate and greater risk for surgical therapy. This approval expands the indications for use to patients at low risk for surgical therapy.

How does it work? The doctor compresses the SAPIEN 3 or SAPIEN 3 Ultra THV and places it on the end of a tube-like device called a balloon catheter. The doctor then inserts the SAPIEN 3 or SAPIEN 3 Ultra THV through an artery in the leg, the artery in the neck, or through a small cut between the ribs. The catheter is pushed through the blood vessels until it reaches the diseased aortic valve. The valve is then expanded by a balloon and it anchors to the diseased valve. Once the new valve is in place, it functions the same as the old valve, opening and closing like a door to force the blood to flow in the correct direction.

When is it used? The SAPIEN 3 are SAPIEN 3 Ultra THVs are used in patients whose own aortic heart valve is diseased due to calcium build up, which causes the valve to narrow ( aortic stenosis) and restricts blood flow through the valve. As the heart works harder to pump enough blood through the smaller opening, it eventually becomes weak. This can lead to symptoms and life-threatening heart problems such as fainting, chest pain, heart failure, irregular heart rhythms ( arrhythmias), or cardiac arrest. Once symptoms of severe aortic stenosis occur, over half of patients die within two (2) years if the diseased valve is not replaced.

The SAPIEN 3 and SAPIEN 3 Ultra THVs should only be used in patients who are considered to be appropriate for the transcatheter heart valve replacement therapy by their heart team (including a surgeon).

What will it accomplish? The SAPIEN 3 and SAPIEN 3 Ultra THVs can improve blood flow in patients with aortic stenosis. In the clinical study of the SAPIEN 3 THV, the device was shown to be reasonably safe and effective for treating patients with severe aortic stenosis without the need for open-heart surgery. The risk of death, disabling stroke, or rehospitalization (valve-related, procedure-related, or heart failure-related) at 1 year was about 9 out of 100 patients (8.5%) in those receiving a SAPIEN 3 THV, as compared to about 16 out of 100 (15.1%) patients in those receiving open-heart surgery.

Any procedure to replace the aortic valve carries the risk for serious complications. The serious complications associated with implanting a SAPIEN 3 or SAPIEN 3 THV include death, stroke, acute kidney injury, heart attack, bleeding, and the need for a permanent pacemaker. For some patients with coexisting conditions or diseases, the risks may be especially high.

Patients should discuss with their doctors the benefits and risks of these two devices.

When should it not be used? The SAPIEN 3 and SAPIEN 3 Ultra THVs should not be used in patients who:

have an infection in the heart or elsewhere.

cannot tolerate blood thinning medicines.

Additional information (including warnings, precautions, and adverse events): Summary of Safety and Effectiveness and labeling are available online at:
Other Resources:

# data[].attributes.attachment_link.title
Edwards SAPIEN 3 Transcatheter Heart Valve System and Ultra THV System

# data[].attributes.attachment_link.description
The Edwards SAPIEN 3 THV System and Edwards SAPIEN 3 Ultra THV System were previously approved for the treatment of severe aortic stenosis (a narrowing of the aortic valve that restricts blood flow to aorta, the body's main artery) in patients at intermediate and greater risk for surgical therapy.

# data[].attributes.body
Long-term durability unknown
Surgical heart valves approximate life span 15 years while TAVR valve has an uncertain life span
Blood thinners
Anatomical limitations: sizing of valve, peripheral vascular disease, bicuspid valves
Pacemaker dependent rate 10% thus increasing cost of TAVR procedure
Costly: Surgical heart valves $6,000 TAVR heart valves $30,000

# data[].attributes.body
Analytical Angelica is smart, thorough, and comfortable with numbers, figures, and charts needed to forecasts upfront, potential, and future costs.
Futuristic Faith is creative and inspiring which will be helpful with designer graphics and marketing campaign.
Includer Isabelle will keep the team engaged and motivated.
Individualization Ivy appreciates the differences in others helping build the relationships within our team.
Woo William who never meets a stranger will get the word out.

# data[].attributes.body
Aortic Valve Stenosis (AS) is a condition caused by accumulation of calcium that narrows the heart valve that progressively worsens ultimately leading to sudden death. Traditionally, AS was treated with open heart surgery, opening the chest, cutting out the diseased valve and replacing it with either a tissue or mechanical heart valve. Transcatheter Aortic Valve Replacement (TAVR) implants the prosthetic heart valve into your native valve via a catheter in lieu of surgery, mostly via the femoral artery. The calcification of the native valve allows the TAVR valve to stay in place without suturing.