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Lioness Device: An Effective Way of Helping in the Prevention of Preterm Birth

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Lioness Device: An Effective Way of Helping in the Prevention of Preterm Birth

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Cristina Sanchez

The University of Texas at Tyler, School of Nursing

NURS 5324.61 : Health Care Informatics

Melinda Hermanns, PhD, RN, PMH-BC, CNE, PN/FCN, ANEF

March 19, 2022

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Premature birth has become more common in the recent decades and one of the most dangerous problems in obstetrics. There are millions of babies born each year around the world that die or face long-term disabilities throughout their life. This not only causes a burden to families having their newborns hospitalized, but also financially unstable. Dr. David Shashar, CEO and founder of PregnanTech in 2018, along with other gynecologists and obstetricians from Israel’s Sheba Medical Center and engineers from Trendlines Labs developed an innovative device to help with preterm birth.  The Lioness device, by PregnanTech is a silicone ring device that is placed high in the cervix that is nonsurgical and simple that can be placed within minutes at the doctor’s office or clinic. This device stays in place and serves to keep the cervix elongated and closed with or without the presence of contractions. This reduces the load on the cervix and is intended to delay premature births for a period of weeks.

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Author: Medgadget

Date Published: August 6, 2020

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Premature birth remains a huge clinical challenge, often resulting in lifelong consequences for both children and mothers. Even in developed nations, preterm birth is the most common cause of mortality for children under five years of age. In many cases, spontaneous onset of labor occurs and it is challenging to prevent this using current methods such as medications, surgery, or hormones.

A company called PregnanTech out of Misgav, Israel has now designed an implantable device that reduces the load on the cervix, keeps the cervix elongated despite contractions, and thereby delays the biomechanical cascade and prevents the breakup of the collagen network that leads to spontaneous birth. The LIONESS, as it's called, is currently being tested in a clinical safety trial in women who are about to undergo hysterectomies. Next year the company plans to have its device trialed at King's College Hospital, London, in pregnant women at high risk of preterm birth

The LIONESS is placed via the vagina in a minimally invasive procedure using an accompanying delivery system. It should take only a few minutes to complete the procedure and the woman will be able to go home right away.

"From my experience as a gynecologist, I know very well the extent of the phenomenon and the suffering it entails for newborns and families. Each extra week in the womb is critical for fetal development, and just one additional week can be the difference between a baby growing up healthy and a baby suffering from a variety of problems during its life," said Dr. David Shashar (MD, Ob/Gyn, MBA, BME), the CEO of PregnanTech. "Between 9% and 17% of all pregnancies are at risk of premature birth. This is a large target market. There are no successful solutions today and the health systems are desperate for it. Leading doctors in Israel and around the world see our product as a breakthrough."

Here's a video explaining the PregnanTech solution:

Link: PregnanTech homepage...

Via: PregnanTech's announcement (PDF)

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LIONESS Device to Help Prevent Preterm Birth

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Premature birth remains a huge clinical challenge, often resulting in lifelong consequences for both children and mothers. Even in developed nations, preterm birth is the most common cause of mortality for children under five years of age. In many cases, spontaneous onset of labor occurs and it is challenging to prevent this using current methods such as medications, surgery, or hormones.

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-This implantable device that is placed high in the cervix and keeps the cervix elongated despite contractions.
-Eliminates the need for hospitalization, medications, surgery, or hormones.
-It is made out of silicone to reduce the risk of allergic reactions.
-It is simple and nonsurgical, can be placed within minutes at the doctors office or clinic.

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My team members would include:

1. Alice- (Achiever-Executing) Alice would be a great team member because she would be a hard worker and motivate everyone else in the team to get things done in a timely manner.

2. Brandon – (Belief-Executing) Brandon will be a great team member because we need someone who sets priorities and does not get distracted. He is very responsible and we need that person that we can count on if we get side tracked.

3. Daisy – (Developer-Relationship Building) Daisy would make a great addition to the team because she will identify and recognize each members potential in specific areas.  She will serve as a great coach in enjoying helping everyone succeed.

3. Daniel- (Discipline-Executing) We need a good planner in the group. Daniel could fill those shoes. He is structured and productive and because I am an achiever, I love being productive.

4. Faith- (Futuristic-Strategic Thinker) Faith will be a great member in our group because she is a dreamer. She is future orientated, imaginative, and creative. Having her inspire us to visualize different things instead of just that can work best than just choosing first option.

5. Pablo (Positivity-Relationship Builder) Pablo will be a very important member in our group because we need someone that can keep everyone positive. Sometimes groups can get overwhelmed, but with his optimistic and enthusiastic energy he will keep everyone motivated to get projects done.

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My strengths using the Clifton StrengthsFinders are:

1.Command (Influencing)

2. Learner (Strategic Thinking)

3. Competition (Influencing)

4. Significance (Influencing)

5. Focus (Executing)

The strengths identified in the Clifton StrengthsFinders would make me a valuable team member. My top strength is command. I can take control of a situation and make decisions. It also identified me as a learner. I have a strong desire to learn and want to continuously improve, catch on quickly, and interested in many things. Another strength is competition. I am motivated driven to compete in contests, especially be a great team leader when competing to win first place. Also significance means that I am independent and being recognized for my hard work and achievements.  I like to influence others to become independent and be recognized for their hard work as well. My last strength was focus. I take a direction, follow through, and make the
corrections necessary to stay on track. I like to prioritize, and then act.  I am a goal setter and very dedicated to what I want to achieve.

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-Currently a clinical safety trial in women about to undergo hysterectomies.
-A clinical trial in pregnant women at risk for preterm birth is planned at King's College Hospital in London.

-Could have an allergic reaction to the silicone material.
-Could have a device malfunction or failure, therefore not help with preterm birth.
-Not enough data on risks of having this device in place.

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https://youtu.be/LZJ3ED9L7hw

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I think the Lioness device will be a great alternative in reducing the number of preterm births. The Lioness device, a silicone ring device that is placed high in the cervix to serves to keep the cervix elongated and closed despite whether having contractions. This device delays the biomechanical cascade and prevents the breakup of the collagen network that leads to spontaneous birth. Also, this is a simple and minimally invasive technique that takes the physicians a few minutes to insert in office versus admitting patients at risk for preterm in the hospital, performing surgery, or administering medications. The Lioness device was discovered in Israel in 2018, and still undergoing clinical trials and goal is to introduce this device worldwide. After learning and reading about this innovative device, it can lower the risk of preterm births.

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Gallup, I. (2019). CliftonStrengths. Gallup.com. https://www.gallup.com/cliftonstrengths/en/252137/home.aspx

Lioness Device to Help Prevent Preterm Birth | Medgadget. (n.d.). Retrieved March 18, 2021, from https://www.medgadget.com/2020/08/lioness-implant-to-help-prevent-preterm-birth.html

PregnanTech. (n.d.). Www.youtube.com. Retrieved
March 18, 2022, from https://youtube.com/watch?v=LZJ3ED9L7hw