Medical Device

Abbott today announced the U.S. Food and Drug Administration has approved updated labeling for the company's HeartMate 3™ heart pump to be used in pediatric patients with advanced refractory left ventricular heart failure. With the updated labeling, physicians now have additional options for treating this underserved population awaiting a heart transplant or for those not eligible to receive a transplant as a ...

Abbott (NYSE: ABT) today announced the U.S. Food and Drug Administration (FDA) has approved updated labeling for the company's HeartMate 3™ heart pump to be used in pediatric patients with advanced refractory left ventricular heart failure. With the updated labeling, physicians now have additional options for treating this underserved population awaiting a heart transplant or for those not eligible to receive a transplant as a result of potential complications or risk related to the procedure.

The approval follows similar pediatric innovations for Abbott in recent years, including the Masters HP™, a 15mm pediatric heart valve the size of a dime, approved in 2018; and the Amplatzer Piccolo™ Occluder, a pea-sized plug approved in 2019 to help treat a potentially life-threatening opening in the heart of some premature or newborn babies.

Many children and adolescents with congestive heart failure require a heart transplant or mechanical device implant to survive. The HeartMate 3 left ventricular assist device (LVAD) – or heart pump – is an implantable device that pumps blood through the body in people whose heart is too weak to do so on its own. The HeartMate 3 pump was initially approved in the United States in 2017 for adults awaiting a heart transplant and received FDA approval for long-term use in adults in 2018. In the largest LVAD trial in the world, the HeartMate 3 pump showed a survival rate of 79% at two years – an outcome comparable to patients receiving a heart transplant.

"For families with children battling chronic diseases the future is often bleak. As physicians, we see the fear in the eyes of not only the child, but also the mothers and fathers," said Robert L. Kormos , M.D., divisional vice president, global medical affairs, Abbott's heart failure business. "Imagine a child with a heart condition that does not allow them to play with friends, sing or run. Innovations, such as the HeartMate 3, can lessen the crippling effects of heart failure and allow that child to live a more normal life."

LIFE-CHANGING COLLABORATION IN ACTION

The updated labeling for HeartMate 3 to be used in pediatric patients was supported by clinical data from the Advanced Cardiac Therapies Improving Outcomes Network ( ACTION Learning Collaborative), a consortium of 50+ U.S. pediatric hospitals that pooled together data to show advantageous outcomes of the HeartMate 3 in pediatric patients.

"Our mission is to improve the outcomes of children with heart failure. Historically, this has been an underfunded and understudied area in pediatrics," said Angela Lorts , M.D., M.B.A., and David Rosenthal , M.D., co-founders of ACTION Learning Collaborative. "This technology will benefit our pediatric patients and is a leap forward for improving heart failure outcomes in children. We are honored to collaborate with Abbott on this pediatric initiative."

BACK TO LIVING LIFE ON HER TERMS

Katrina Sellens , now 16-years-old, was an active teenager before being diagnosed with cardiomyopathy, a serious disease of the heart muscle that can lead to heart failure. She couldn't walk 10 feet without feeling exhausted and had to bend over just to breathe. In 2019, Katrina received the Abbott HeartMate 3 under a special request to treat her life-threatening disease.

"One of the most depressing aspects of heart failure is seeing your child lose the ability to do what had always come naturally," said Maria Bautista , Katrina's mother. "I didn't believe she would get as strong as she has with the HeartMate 3. We are back to living life on her terms."

Nearly two years later, Katrina is back to camping and taking care of her family's chickens. The high school sophomore recently earned her driver's permit and dreams of becoming an LVAD nurse so she can help others with heart failure. For more on Katrina's story, click here.

Resources to Learn More

Heart failure is a manageable condition, especially if it is detected early. Cardiologists and other healthcare providers can visit Abbott Cardiovascular for more resources on the latest innovations and solutions designed for patients with heart failure.

About Abbott's HeartMate 3 heart pump

Abbott's HeartMate 3™ heart pump is a small, implantable mechanical circulatory support device for advanced heart failure patients who are awaiting transplantation or are not candidates for heart transplantation. It is the first commercially approved (CE Mark and FDA approved) heart pump with Full MagLev technology, which allows the device's rotor to be "suspended" by magnetic forces. This design aims to reduce trauma to blood passing through the pump and improve outcomes for patients.

For U.S. important safety information for the HeartMate 3, visit https://www.cardiovascular.abbott/us/en/campaigns/heartmate-3-lvad-pediatric.html .

For U.S. important safety information for the Masters HP Series, visit http://abbo.tt/2taeyVL .

For U.S. important safety information for the Amplatzer Piccolo Occluder, visit https://www.structuralheartsolutions.com/us/piccolo-ISI .

About Abbott

Abbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals and branded generic medicines. Our 107,000 colleagues serve people in more than 160 countries.

Connect with us at www.abbott.com , on LinkedIn at www.linkedin.com/company/abbott-/ , on Facebook at www.facebook.com/Abbott and on Twitter @AbbottNews.

Cision View original content: http://www.prnewswire.com/news-releases/fda-approves-labeling-update-for-abbotts-heartmate-3-heart-pump-for-use-in-pediatric-patients-301195626.html

SOURCE Abbott

News Provided by PR Newswire via QuoteMedia

Johnson & Johnson to Participate in Citi's 2022 Virtual Healthcare Conference

- Johnson & Johnson (NYSE: JNJ) will participate in Citi's 2022 Virtual Healthcare Conference on Wednesday, February 23 rd Ashley McEvoy Executive Vice President, Worldwide Chairman, Medical Devices will represent the Company in a session scheduled at 11:00 a.m. (Eastern Time) .

This conference call will be available to investors and other interested parties by visit the Johnson & Johnson website at www.investor.jnj.com .

Keep reading... Show less

Thermo Fisher Scientific Earns Top Score for LGBTQ+ Workplace Equality for Seventh Consecutive Year

Thermo Fisher Scientific Inc., (NYSE:TMO), the world leader in serving science, received a score of 100 on the Human Rights Campaign Foundation's 2022 Corporate Equality Index (CEI) for the seventh consecutive year. As the national benchmarking tool measuring policies, practices and benefits pertinent to lesbian, gay, bisexual, transgender and queer (LGBTQ) employees, the CEI is a driving force for LGBTQ+ workplace inclusion.

Keep reading... Show less

Bausch Health Announces Launch Of Private Offering Of Senior Secured Notes

Bausch Health Companies Inc. (NYSETSX: BHC) ("Bausch Health" or the "Company") announced today that it has launched an offering of $1.0 billion aggregate principal amount of new senior secured notes due 2027 (the "Notes"). As previously announced, the Company is also seeking to refinance its existing credit agreement (the "Credit Agreement" and such refinancing, the "Credit Agreement Refinancing"). The refinanced Credit Agreement is expected to consist of approximately $2.5 billion of term B loans (the "New Term B Loans") and a $975 million revolving credit facility. The Credit Agreement Refinancing is expected to occur upon completion of the initial public offering ("IPO") of Bausch + Lomb Corporation ("Bausch + Lomb" and such offering, the "Bausch + Lomb IPO") and a related debt financing by Bausch + Lomb (the "Bausch + Lomb Debt Financing").

The proceeds from the offering of the Notes, along with the expected proceeds from the New Term B Loans, the Bausch + Lomb IPO and the repayment of an intercompany note owed to us by Bausch + Lomb (which repayment is expected to be funded by the Bausch + Lomb Debt Financing), are expected to be used to fund the Company's previously announced conditional redemption in full of its outstanding 6.125% Senior Notes due 2025 (the "6.125% Notes due 2025"), refinance all of the existing Term B Loans, fund the Company's previously announced conditional partial redemption of its outstanding 9.000% Senior Notes due 2025 (the "9.000% Notes due 2025 and, collectively with the 6.125% Senior Notes due 2025, the "Existing Notes") and to pay related fees, premiums and expenses.

Keep reading... Show less

Danaher Reports Fourth Quarter And Full Year 2021 Results

- Danaher Corporation (NYSE: DHR) (the "Company") today announced results for the fourth quarter and full year 2021. All results in this release reflect only continuing operations unless otherwise noted.

For the quarter ended December 31, 2021 , net earnings were $1.8 billion , or $2.39 per diluted common share which represents a 44.0% year-over-year increase from the comparable 2020 period.

Keep reading... Show less

Abbott Reports Strong Fourth-Quarter 2021 Results; Issues 2022 Forecast

Abbott (NYSE: ABT) today announced financial results for the fourth quarter and full year ended Dec. 31, 2021 and issued its financial outlook for 2022.

  • Fourth-quarter sales of $11.5 billion increased 7.2 percent on a reported basis and 7.7 percent on an organic basis, which excludes the impact of foreign exchange.
  • Fourth-quarter GAAP diluted EPS was $1.11 and adjusted diluted EPS, which excludes specified items, was $1.32 .
  • Full-year 2021 GAAP diluted EPS from continuing operations was $3.94 and adjusted diluted EPS from continuing operations was $5.21 , reflecting 42.7% growth versus the prior year. 1
  • Global COVID-19 testing-related sales were $2.3 billion in the fourth quarter and $7.7 billion for the full-year. Abbott has distributed more than 1.4 billion COVID-19 tests since the start of the pandemic.
  • Abbott issues full-year 2022 guidance for diluted EPS from continuing operations on a GAAP basis of at least $3.43 and full-year adjusted diluted EPS from continuing operations of at least $4.70 .
  • Full-year 2022 guidance includes an initial COVID-19 testing-related sales forecast of $2.5 billion , which Abbott expects to occur early in the year and will update on a quarterly basis.
  • Abbott's R&D pipeline continues to deliver a steady cadence of new products. Select 2021 highlights include U.S. Centers for Medicare & Medicaid Services expanded reimbursement for MitraClip ® , U.S. launches of Amplatzer ® Amulet ® , NeuroSphere Virtual Clinic, and Portico ® transcatheter aortic valve replacement (TAVR) system, along with the international launch of Navitor TAVR system.

"2021 was an outstanding year for Abbott," said Robert B. Ford , chairman and chief executive officer, Abbott. "We achieved more than 40 percent EPS growth, exceeding the baseline EPS guidance we set at the beginning of last year and, importantly, continued to advance our new product pipeline across the portfolio."

Keep reading... Show less
Avricore Health CEO and Special Guests Join Radius Research for Investor Update

Avricore Health CEO and Special Guests Join Radius Research for Investor Update

Avricore Health INC. (TSXV: AVCR) (the " Company " or " AVCR ") is excited to be joined by Shoppers Drug Mart Pharmacist and Associate Owner, Mohamad Adel Elsabakhawi and Abbott Rapid Diagnostics' General Manager Daniel St. Pierre and National Sales Manager, Soul Khan.

"The Company enjoyed an incredible year in 2021, and throughout the Holidays and the beginning of the New Year, we have continued to finalize key agreements which will lead to substantial growth this year." said Avricore Health CEO, Hector Bremner. "Our partners are as excited as we are and we look forward to deepening our collaboration."

Keep reading... Show less

Latest Press Releases

Related News

×