Business Wire

Largest Observational Study to Date of the St. Jude Medical AMPLATZER Amulet Left Atrial Appendage Occluder Demonstrates High Implant Success and Strong Safety Profile

Del

St. Jude Medical, Inc. (NYSE:STJ), a global medical device company, today presented favorable results from the largest observational study to date of the company’s AMPLATZER™ Amulet™ left atrial appendage (LAA) occluder. The data were presented in a Late Breaking Clinical Trial session at the Transcatheter Cardiovascular Therapeutics (TCT) Conference in Washington, D.C.

This Smart News Release features multimedia. View the full release here: http://www.businesswire.com/news/home/20161102005979/en/

The St. Jude Medical(TM) AMPLATZER(TM) Amulet(TM) device is used to completely seal off the left atr ...

The St. Jude Medical(TM) AMPLATZER(TM) Amulet(TM) device is used to completely seal off the left atrial appendage (LAA) in patients diagnosed with non-valvular atrial fibrillation (AF). Sealing off the LAA in patients with AF may prevent the risk of blood clot formation and release, potentially reducing that risk. (Photo: St. Jude Medical)

The prospective, multicenter, international AMPLATZER Amulet Observational Study of LAA occlusion (closure) enrolled 1,073 patients at 64 centers across 18 countries. Initial results from the study showed a 98.8 percent implant success rate adding to the clinical evidence that the AMPLATZER Amulet LAA Occluder is a safe alternative for prevention of stroke in patients with non-valvular atrial fibrillation (AF).

The AMPLATZER Amulet LAA Occluder is used to close the LAA (an appendage of the left atrium) in patients diagnosed with non-valvular AF. Atrial fibrillation occurs when the upper chambers of the heart (atria) contract rapidly and irregularly, which can disrupt efficient pumping of the blood out of the heart. Blood that pools in the atria can clot and, if the clot moves to an artery in the brain, stroke may occur. Studies have shown that AF can dramatically increase the risk of stroke for patients and for many patients, medication has historically been the option physicians turn to most often.

“Patients with atrial fibrillation at risk of stroke are usually prescribed anticoagulant medication, but this treatment comes with some limitations. Patients might not tolerate the medication, plus there’s a risk for major bleeding,” said Dr. David Hildick-Smith from Sussex Cardiac Centre at Brighton and Sussex University Hospitals Brighton, United Kingdom and principal investigator of the AMPLATZER Amulet Observational Study. “By closing the LAA with the AMPLATZER Amulet device, physicians can seal off the LAA, with the objective of reducing the risk of stroke and eliminating the need for oral anticoagulants.”

Other key findings of the Amulet Observational study include:

  • Closure rate was 99 percent at one to three month follow-up visit (n=364). Closure was defined as absence of flow or flow of < 3 mm jet into the LAA. All echocardiography results were adjudicated by an independent core lab.
  • Acute device/procedure related major adverse events within seven days post procedure occurred in 2.7 percent (29) of 1,073 patients.

“Initial data from this large-scale observational study continue to affirm the AMPLATZER Amulet LAA Occluder as an important treatment option to reduce the risk of stroke in patients with non-valvular AF,” said Dr. Srijoy Mahapatra, medical director and vice president of medical affairs at St. Jude Medical. “The AMPLATZER Amulet Occluder has favorable closure rates when compared to other device reports in a similar patient group.”

The AMPLATZER Amulet Left Atrial Appendage Occluder is CE Mark approved, but remains an investigational device in the United States. In September, St. Jude Medical announced the start of the AMPLATZER™ Amulet™ LAA Occluder IDE trial, evaluating the safety and effectiveness of the company’s AMPLATZER Amulet occluder device. The trial will enroll patients at up to 100 sites in the United States and an additional 50 sites internationally.

The shape and size of an LAA can vary greatly. The AMPLATZER Amulet LAA Occluder has a conformable disc and lobe designed for complete occlusion of the LAA and offers the broadest size range available. The device offers physicians options to help meet the anatomical demands of patients in need of LAA closure.

About Atrial Fibrillation and Stroke

During AF, chaotic electrical signals in the heart’s upper chambers (atria) beat erratically and out of sync with the two lower chambers, resulting in poor blood flow. The LAA is a tube-shaped appendage connected to the left atrium of the heart that can potentially hold static blood during an episode of AF, increasing the likelihood of clot formation. Research shows that in AF patients, approximately 90 percent of all cardiac blood clots form in the LAA. If a clot forms in the LAA and is then released into the heart, it may enter blood circulation, travel to the brain, block a vessel and cause an ischemic stroke. The current standard of care to treat ischemic stroke in AF patients is blood-thinning medications, which comes with major, sometimes fatal, bleeding risks.

According to the World Health Organization (WHO), an estimated 15 million strokes occur worldwide each year. In 2010, stroke cost the United States an estimated $53.9 billion in health care services, medications and missed days of work.

About St. Jude Medical

St. Jude Medical is a leading global medical device manufacturer and is dedicated to transforming the treatment of some of the world’s most expensive epidemic diseases. The company does this by developing cost-effective medical technologies that save and improve lives of patients around the world. Headquartered in St. Paul, Minn., St. Jude Medical has five major areas of focus that include heart failure, atrial fibrillation, neuromodulation, traditional cardiac rhythm management, and cardiovascular. For more information, please visit sjm.com or follow us on Twitter @SJM_Media.

Forward-Looking Statements

This news release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 that involve risks and uncertainties. Such forward-looking statements include the expectations, plans and prospects for the company, including potential clinical successes, reimbursement strategies, anticipated regulatory approvals and future product launches, and projected revenues, margins, earnings and market shares. The statements made by the company are based upon management’s current expectations and are subject to certain risks and uncertainties that could cause actual results to differ materially from those described in the forward-looking statements. These risks and uncertainties include market conditions and other factors beyond the company’s control and the risk factors and other cautionary statements described in the company’s filings with the SEC, including those described in the Risk Factors and Cautionary Statements sections of the company’s Annual Report on Form 10-K for the fiscal year ended January 2, 2016 and Quarterly Report on Form 10-Q for the fiscal quarter ended July 2, 2016. The company does not intend to update these statements and undertakes no duty to any person to provide any such update under any circumstance.

Contact information

St. Jude Medical, Inc.
Investor Relations:
J.C. Weigelt, 651-756-4347
jweigelt@sjm.com
or
Media Relations:
Gina O'Connell, 651-756-3380
goconnell02@sjm.com

Om Business Wire

Business Wire
Business Wire
24 Martin Lane
EC4R 0DR London

+44 20 7626 1982http://www.businesswire.co.uk

Business Wire, a Berkshire Hathaway company, is the global leader in multiplatform press release distribution.

Følg saker fra Business Wire

Registrer deg med din epostadresse under for å få de nyeste sakene fra Business Wire på epost fortløpende. Du kan melde deg av når som helst.

Siste saker fra Business Wire

The Brightline Initiative, Project Management Institute and The Boston Consulting Group Host The Economist Events for Davos Panel19.1.2018 21:13Pressemelding

The Brightline™ Initiative, a non-commercial coalition dedicated to helping organizations bridge the gap between strategy design and strategy delivery, along with Project Management Institute (PMI) and The Boston Consulting Group are hosting The Economist Events on the panel discussion, “The Business Case for Openness: Implementing Strategy in a Drawbridge up World.” This event marks Brightline’s debut at Davos. Dovetailing with the World Economic Forum’s overarching theme, “Creating a Shared Future in a Fractured World,” the discussion will address how business leaders can better adapt and implement strategies to promote openness and collaboration. PMI, a founding coalition member of Brightline, is particularly passionate about this topic, given the fact that they focus on collaborating with world-leading organizations to improve infrastructure initiatives in developing and mature communities around the world. “Today the challenges to sustainable growth through strategy implementation

New US Patent for Solidia Technologies’ CO2-cured Concrete Advances Performance and Sustainability of Building Materials19.1.2018 18:07Pressemelding

The U.S. Patent and Trademark Office issued a patent for the structure of CO2-cured Solidia Concrete™, advancing the performance and sustainability of materials available to the global construction and materials industries. Solidia Technologies® holds the exclusive licensing rights to the patent, which is held by Rutgers University, where the original generation of the material was invented. This press release features multimedia. View the full release here: http://www.businesswire.com/news/home/20180119005608/en/ Solidia Concrete™ pavers. (Photo: Business Wire) U.S. Patent No. 9,868,667, "Bonding Element, Bonding Matrix and Composite Material Having the Bonding Element and Method of Manufacturing Thereof," covers the composition of matter of the non-hydraulic concrete. “The hydrate bonds in conventional concrete can compromise that material’s strength and durability,” explained Solidia Chief Technology Officer Nicholas DeCristofaro, Ph.D. “With CO2-cured concrete, bonding elements bas

Schlumberger Announces Full-Year and Fourth-Quarter 2017 Results19.1.2018 12:00Pressemelding

Schlumberger Limited (NYSE:SLB) today reported results for full-year 2017 and the fourth quarter of 2017. Full-Year Results (Stated in millions, except per share amounts) Twelve Months Ended Change Dec. 31, 2017 Dec. 31, 2016 Year-on-year Revenue $30,440 $27,810 9% Pretax operating income $3,921 $3,273 20% Pretax operating margin 12.9% 11.8% 111 bps Net loss (GAAP basis) $(1,505) $(1,687) n/m Net income, excluding charges and credits* $2,085 $1,550 35% Diluted EPS (loss per share) (GAAP basis) $(1.08) $(1.24) n/m Diluted EPS, excluding charges and credits* $1.50 $1.14 32% *These are non-GAAP financial measures. See section below entitled "Charges & Credits" for details. n/m = not meaningful Full-year 2017 revenue of $30.4 billion increased 9% year-on-year. This included a full year’s activity from the acquired Cameron businesses as compared to three quarters of activity in 2016. Excluding the addition of Cameron, revenue growth was driven by land activity in North America, which increa

The Coca-Cola Company Announces New Global Vision to Help Create a World Without Waste19.1.2018 11:55Pressemelding

The Coca-Cola Company announced today that it is fundamentally reshaping its approach to packaging, with a global goal to help collect and recycle the equivalent of 100% of its packaging by 2030. This press release features multimedia. View the full release here: http://www.businesswire.com/news/home/20180119005104/en/ In 2017, employees from Heartland Coca-Cola Bottling Co. joined with other volunteers in St. Louis to collect and sort 14,480 pounds of debris; 63 percent was diverted for recycling. Coca-Cola then partnered with manufacturer Phoenix Technologies to convert plastic bottles into recycled PET plastic for use in new bottles. (Photo: Business Wire) This goal is the centerpiece of the Company’s new packaging vision for a World Without Waste, which the Coca-Cola system intends to back with a multi-year investment that includes ongoing work to make packaging 100% recyclable. This begins with the understanding that food and beverage containers are an important part of people’s m

Researchers and Scientists from Five Countries Named Winners of King Faisal Prize 201819.1.2018 10:33Pressemelding

Five researchers and scientists from Malaysia, Jordan, Tunisia, the US and the UK have been named winners of the King Faisal Prize 2018 as the 40th edition of the renowned award recognized their distinguished contributions towards humanity. The Prize honours exceptional achievements in five categories: Service to Islam, Islamic Studies, Arabic Language & Literature, Medicine, and Science. This press release features multimedia. View the full release here: http://www.businesswire.com/news/home/20180119005245/en/ His Royal Highness Prince Khalid Al-Faisal, Chairman of King Faisal Prize Board, Abdulaziz (Photo: AETOSWire) Professor Irwandi Jaswir, Deputy Dean of the International Institute for Halal Research and Training (INHART) and Secretary of Council of Professors at the International Islamic University Malaysia (IIUM), has been named the winner in the Service to Islam category for contributions to the development of ‘Halal Science’ and Halal food and consumer goods. Professor Bashar

E.ON Chooses Corinex Broadband over Powerline Technology for their Smart Metering Rollout19.1.2018 06:00Pressemelding

E.ON, an international energy company that serves 32 million customers across multiple countries, has decided to use broadband over powerline (BPL) as the key technology in their communication mix, in the smart metering communication infrastructure for the low voltage part of their grid. E.ON chose Corinex as the solution provider for the initial two years of the deployment. The initial deployment will be several ten thousands of repeaters and head ends providing secure communication for a couple of hundred thousands of households. Corinex Grid Value network management based on IBM Tivoli platform will manage the network. “After extensive field trials, we found that Corinex broadband over powerline technology meets our requirements for mass rollout of smart metering services. We are convinced BPL is ideally suited to address the needs of many other utilities, so E.ON is interested in supporting BPL industry standardization in order to create a broad ecosystem of silicon and system vend

I vårt presserom finner du alle våre siste saker, kontaktpersoner, bilder, dokumenter og annen relevant informasjon om oss.

Besøk vårt presserom