Business Wire

St. Jude Medical Expands Its Heart Failure Portfolio with SyncAV CRT Technology, Providing Physicians Another Option for Managing Patients Not Responsive to Other Therapies

Del

St. Jude Medical, Inc. (NYSE:STJ), a global medical device company, announced CE Mark approval and launch of SyncAV CRT software, designed to build upon the company’s first-to-market MultiPointPacing technology and further optimize St. Jude Medical’s comprehensive cardiac resynchronization therapy (CRT) portfolio. MultiPoint Pacing technology with the SyncAV CRT software algorithm is designed to address and effectively treat heart failure patients who are not responsive to other pacing options. The SyncAV technology, which automatically adjusts pacing based on real-time changes in a patient’s cardiac condition, also provides physicians the opportunity to further improve treatment of patients who have responded positively to traditional CRT.

This Smart News Release features multimedia. View the full release here: http://www.businesswire.com/news/home/20160623005366/en/

Quadra Assura MP CRT-D. Courtesy of St. Jude Medical.

Quadra Assura MP CRT-D. Courtesy of St. Jude Medical.

In addition to the approval of SyncAV CRT software, the company has also received CE Mark approval for the Quadra Assura MP CRT-Defibrillator (CRT-D) with full-body magnetic resonance (MR) labeling. With the updated labeling, patients will have unrestricted access to MRI diagnostic testing. Approvals of the SyncAV CRT software and Quadra Assura MP CRT-D with full-body MRI support the continued rollout of MultiPoint Pacing technology throughout Europe.

“Although we have made substantial improvements in how we treat heart failure patients, there are still certain patients who are not getting the outcomes with traditional CRT that we would like to see. The SyncAV CRT algorithm dynamically individualizes programming to work towards providing patients with the right settings at the right time helping offer the best possible outcome for even our most complex patients,” said Dr. Timothy Betts, consultant cardiologist and electrophysiologist at the Oxford Heart Centre in the John Radcliffe Hospital. “Our goal is to utilize the technology to improve outcomes while offering patients who do not respond to therapy with additional options for treatment.”

For patients suffering from heart failure, CRT technology resynchronizes the lower chambers (ventricles) of the heart by sending uniquely programmed electrical impulses to stimulate each ventricle to beat in sync to offer the best cardiac performance. St. Jude Medical has introduced innovative solutions to enhance its CRT product portfolio to improve the care of the approximately 23 million people worldwide afflicted with congestive heart failure. While studies have shown that CRT can improve the quality of life for many patients with heart failure, some patients do not respond optimally to traditional CRT, leaving physicians with limited options to improve their clinical outcomes for their patients. The latest heart failure offerings by St. Jude Medical will provide physicians and patients additional options that can help maximize the therapeutic effects of CRT.

Clinical Research at Scientific Sessions

The MultiPoint Pacing technology, featured on the Quadra Assura MP CRT-D and the Quadra Allure MP CRT-P, including SyncAV CRT technology, as well as the Quadra Assura MP CRT-D with full-body MRI were all showcased at this year’s annual CARDIOSTIM-EHRA EUROPACE 2016. In addition, the investigational device exemption (IDE) clinical study results for the MultiPoint Pacing technology were presented during a late-breaking clinical trial session at the congress. The MPP IDE study met its primary endpoints of safety and efficacy, and additional analyses indicated a positive impact of MultiPoint Pacing programming on patient response to therapy.

An Italian registry on multipoint left-ventricular pacing in CRT (IRON-MPP) was presented at the congress and also published in Europace. Author and presenter of the data, Dr. Giovanni Forleo, electrophysiologist at the University Hospital of Tor Vergata, Rome, Italy, said, “Our goal with this study was to help build a large body of clinical evidence to inform clinical decision-making standards for the management of heart failure patients implanted with MultiPoint Pacing capable CRT-D devices. The results of this study show that establishing optimal programming with the MultiPoint Pacing technology can realize a maximized benefit for patients.”

CRT includes a lead (Quartet™ Quadripolar LV Lead) placed on the lower left chamber of the heart (ventricle). The left ventricle pumps oxygenated blood from the heart out to the rest of the body. MultiPoint Pacing technology is designed to deliver independent electrical pulses to multiple locations on the Quartet lead to make the heart’s lower chambers pump in a more coordinated way to mirror the natural contractions of a healthy heart. More than 65 abstracts and publications demonstrate that this increases the number of patients who benefit from this type of therapy (CRT), including one presented at the American College of Cardiology (ACC) 2016 meeting in Chicago, which demonstrated a 90 percent responder rate for patients at one year follow-up using MPP programming.

St. Jude Medical also developed and launched the industry’s first quadripolar pacing system in Europe in 2009 featuring four pacing electrodes, offering physicians the ability to effectively and efficiently manage the ever-changing needs of patients with heart failure. The Quartet LV lead design allows the physician to implant the lead in the most stable position without making trade-offs in electrical performance; this has also been demonstrated to reduce the likelihood of costly and invasive lead revision through a second intervention procedure. St. Jude Medical launched the company’s proprietary, first-to-market MultiPoint Pacing technology in Europe in 2014.

The St. Jude Medical MORE CRT MPP clinical study is designed to demonstrate the benefits of the St. Jude Medical MultiPoint Pacing technology in improving patient response to CRT therapy.

About St. Jude Medical’s Heart Failure Business

St. Jude Medical is pioneering heart failure disease management with innovative solutions like the CardioMEMS HF System, ground-breaking quadripolar technology and, in select European markets, the HeartMate 3 left ventricular assist system and our first-to-market MultiPoint Pacing technology. St. Jude Medical collaborates with heart failure specialists, clinicians and advocacy partners to provide a comprehensive product portfolio that includes innovative, cost-effective solutions that help reduce hospitalizations and improve patient quality of life for heart failure patients around the world.

For more information about St. Jude Medical’s focus on heart failure, visit the St. Jude Medical Heart Failure Media Kit or the St. Jude Medical PULSE Blog.

Information for patients to learn more about heart failure can be found at www.heartfailureanswers.com.

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 employs approximately 18,000 people worldwide and 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, 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 April 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.
J.C. Weigelt, 651-756-4347
Investor Relations
jweigelt@sjm.com
or
Kristi Warner, 651-756-2085
Media Relations
kwarner@sjm.com

Om Business Wire

Business Wire
Business Wire
24 Martin Lane
EC4R 0DR London

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

(c) 2018 Business Wire, Inc., All rights reserved.

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

OTEZLA® (Apremilast) Phase III Data Showed Significant Improvements in Patients with Active Behçet’s Disease with Oral Ulcers17.2.2018 21:00Pressemelding

Celgene Corporation (NASDAQ:CELG) today announced that data from the phase III RELIEF™ clinical trial of OTEZLA® (apremilast) in patients with active Behçet’s Disease with oral ulcers were presented in a late-breaking oral presentation at the 2018 American Academy of Dermatology (AAD) Annual Meeting. The results showed statistically significant reductions in oral ulcers with apremilast 30 mg twice daily (BID) versus placebo through week 12. OTEZLA (apremilast) is Celgene’s oral selective inhibitor of phosphodiesterase 4 (PDE4). Behçet’s Disease is a rare, chronic, multi-system inflammatory syndrome. Oral ulcers, the most common manifestation of Behçet’s Disease, can be disabling and have a substantial effect on quality of life. This study primarily evaluated the effect of apremilast on recurring oral ulcers in patients with active Behçet’s Disease who were previously treated with at least one topical or systemic medication. “Reducing oral ulcers, which are painful and can negatively im

CT-P13 (biosimilar infliximab) is comparable to reference infliximab and adalimumab in highly anticipated real-world study17.2.2018 08:00Pressemelding

Twelve-month data from the Personalised Anti-TNF therapy in Crohn’s disease Study (PANTS) was presented at the 13th Congress of the European Crohn’s and Colitis Organisation (ECCO). The results indicate that the clinical effectiveness, safety and immunogenicity of Celltrion Healthcare’s CT-P13 (biosimilar infliximab) in patients with Crohn’s disease (CD) is comparable to those treated with reference infliximab as well as those treated with adalimumab.1 The UK-wide, three-year prospective observational study investigated primary non-response (PNR), loss of response (LOR) and adverse drug reactions (ADR) to infliximab (reference infliximab and CT-P13) and adalimumab in 1610 CD patients. The data show comparable efficacy between CT-P13, reference infliximab and adalimumab in relation to PNR, LOR and ADR rates. In addition, at week 54, the remission rate was 39.7%, 39.0% and 32.7% for reference infliximab, CT-P13 and adalimumab treated patients, respectively.1 The PANTS study investigates

Avanti Communications HYLAS 4 Satellite Arrives in French Guiana16.2.2018 18:26Pressemelding

Avanti Communications Group plc (“Avanti”), a leading provider of satellite data communications services in Europe, the Middle East and Africa (“EMEA”), announces its HYLAS 4 satellite has arrived safely in French Guiana ahead of its March 2018 launch. This press release features multimedia. View the full release here: http://www.businesswire.com/news/home/20180216005586/en/ Avanti Communications HYLAS 4 Satellite Arrives in French Guiana (Photo: Business Wire) The spacecraft, built by Orbital ATK was packed and shipped at their Satellite Manufacturing Facility in Dulles, Virginia, United States and flown to French Guiana, where it was unloaded and will be taken to the Arianespace launch facilities in Kourou. HYLAS 4 uses the latest High Throughput Satellite technology, doubling Avanti's Ka-band capacity across EMEA. The latest addition to Avanti's HYLAS fleet will provide: Backhaul services for mobile network operators Wholesale broadband for ISPs Connectivity for governments (civil a

General Cable Corporation Stockholders Approve Acquisition By Prysmian Group16.2.2018 17:05Pressemelding

General Cable Corporation (NYSE: BGC) today announced the voting results from the Company’s special meeting of stockholders held this morning. Stockholders of General Cable approved the Company’s previously announced acquisition by Prysmian Group (BIT: PRY) for $30.00 per share in cash. A total of 38,140,754 shares, representing approximately 75.34% of the total number of shares of common stock outstanding and approximately 99% of the total votes cast, were voted in favor of the merger. Subject to regulatory approvals and other customary closing conditions, the transaction is expected to close by the third quarter of 2018. About General Cable General Cable (NYSE:BGC), with headquarters in Highland Heights, Kentucky, is a global leader in the development, design, manufacture, marketing and distribution of aluminum, copper and fiber optic wire and cable products for the energy, communications, automotive, industrial, construction and specialty segments. General Cable is one of the larges

Systemic Sclerosis World Congress:Inspirational Patient Stories Reveal the Challenging Realities of Living with Devastating Rare Disease16.2.2018 09:03Pressemelding

Boehringer Ingelheim today unveils a new phase of 'More Than Scleroderma: The Inside Story', and launches the new patient website www.morethanscleroderma.com. This press release features multimedia. View the full release here: http://www.businesswire.com/news/home/20180216005188/en/ Anna, 36, living with scleroderma (Photo: Business Wire) The global initiative highlights the importance of understanding the ‘inside story’ of each individual living with scleroderma, also known as systemic sclerosis. To coincide with the Systemic Sclerosis World Congress in Bordeaux, 15-17 February 2018, new and truly inspiring patient stories are revealed, reflecting the real-life, diverse and very moving journeys of people living with scleroderma across the world. The campaign will also be launched in the U.S. The new website www.morethanscleroderma.com features a powerful collection of photographs and video stories of people living with scleroderma across the world, revealing the life-changing impact o

Philip Morris International Recognized as a Global Top Employer for the Second Year in a Row16.2.2018 08:00Pressemelding

Philip Morris International Inc. (PMI) (NYSE/Euronext Paris: PM) today is recognized for the second year in a row as a Global Top Employer. This year’s certification from the Top Employer Institute is awarded to PMI teams in 44 countries, a testament to the company’s consistency and excellence in offering an enriching and dynamic work environment, and exceptional development opportunities for employees across the globe. PMI has been recognized by the Top Employer Institute for six consecutive years. This year, PMI was awarded with five regional certifications in Europe, the Middle East, Africa and, for the first time, in North America and Latin America. Additionally, Indonesia was the first PMI affiliate to be certified in Asia. “It is a proud moment for all of us at PMI,” said Charles Bendotti, PMI Senior Vice President, People and Culture. “Our success as a company relies on the men and women who come to work every day with a passion to achieve, and a willingness to learn, grow, and