St. Jude Medical Gains CE Mark for 27mm & 29mm Portico TAVR Valves to Complete a Full Portfolio of Portico Sizing Options for Physicians Treating Patients with Aortic Stenosis
18.9.2015 12:00 | Business Wire
St. Jude Medical, Inc. (NYSE:STJ), a global medical device company, today announced the European CE Mark approval for the 27mm and 29mm Portico™ Transcatheter Aortic Valve Replacement System. The approval follows previous approvals of the 23mm and 25mm Portico valves, allowing St. Jude Medical to offer physicians an expanded range of fully repositionable, retrievable TAVR valve sizes. The Portico valve accommodates a patient’s native anatomy with diameters ranging from 19 to 27 mm.
Aortic stenosis is one of the most common forms of cardiovascular disease in the world, and develops as the aortic heart valve becomes calcified, narrowing the valve and preventing a complete opening. Over time, aortic stenosis disrupts the blood flow from the heart, which causes the heart to pump harder and results in weakening. TAVR procedures provide physicians an additional treatment option for patients with severe aortic stenosis who are considered high risk for open heart surgery.
“Aortic stenosis is a serious, potentially life-threatening condition for patients who are unable to receive a traditional open-heart valve transplant,” said Dr. Helge Mollmann, the cardiology head of Transcatheter Valve Therapies at Kerckhoff Heart Center Bad Nauheim, Germany. “Transcatheter aortic valve replacement has revolutionized how we treat these patients, and by offering a complete portfolio of Portico valve sizing options, St. Jude Medical has further helped broaden the patient population that can be treated with this family of valves.”
The Portico system was developed to simplify TAVR procedures for physicians by improving control, ease of use and accuracy over other commercially-available TAVR valves. The system offers the ability for the Portico valve to be fully recaptured and repositioned prior to full deployment and release from the delivery system, providing physicians more options to place the valve in the targeted location. The Portico system has also demonstrated low rates of permanent pacemaker utilizations post valve implant as a result of heart block and was designed to minimize the risk of paravalvular leak (a leakage of blood caused by a space between the heart tissue and a replacement valve).
“Transcatheter aortic valve replacement is a complex procedure, and feedback from physicians worldwide has continued to press upon us the fact that offering a system that provides physicians more control and a simplified procedure is important,” said Eric Fain, M.D., group president at St. Jude Medical. “In developing our Portico valve, we took such feedback into account, designing a full portfolio of sizing to ensure physicians could comfortably rely on one device family for a range of patients.”
During a transfemoral implant procedure, the Portico valve is delivered by catheter through the femoral artery in the leg and is positioned while the patient’s heart continues to beat. Use of the Portico valve alleviates the use of cardiopulmonary bypass, which involves a machine taking over a patient’s heart and lung function during surgery and can cause added strain on an already frail heart.
The 23mm the 25mm Portico Transcatheter Aortic Heart Valve are both CE Mark approved and commercially available in Europe. In the United States, the Portico valve is currently being evaluated in a clinical trial through an investigational device exemption (IDE) by the U.S. Food and Drug Administration (FDA). The Portico IDE trial originally launched in May 2014, and is designed to support U.S. approval of the Portico system.
About St. Jude Medical
St. Jude Medical is a global medical device manufacturer 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 four major clinical focus areas that include cardiac rhythm management, atrial fibrillation, cardiovascular and neuromodulation. For more information, please visit sjm.com or follow us on Twitter @SJM_Media.
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 3, 2015 and Quarterly Report on Form 10-Q for the fiscal quarter ended July 4, 2015. The Company does not intend to update these statements and undertakes no duty to any person to provide any such update under any circumstance.
Om Business Wire
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
Tech21 Announces New Collection Designed to Protect the Samsung Galaxy Note8 Drop After Drop.23.8.2017 17:30 | Pressemelding
Tech21, the leader in impact protection for mobile devices, today announced a new collection of innovative cases and screen shields for the Samsung Galaxy Note8 made of unique, patented impact protection materials that guarantee the most effective drop protection on the market. This Smart News Release features multimedia. View the full release here: http://www.businesswire.com/news/home/20170823005888/en/ Evo Tactical for Samsung Galaxy Note8 (Photo: Business Wire) Tech21 products are designed to protect, drop after drop. The company does this by using scientifically proven impact materials, innovative design and a rigorous testing methodology developed in partnership with the National Physical Laboratory. Tech21 cases are drop tested 20 times to ensure durability and long lasting protection able to withstand the multiple drops that occur in the everyday
2018 AQR Insight Award Call for Papers23.8.2017 15:45 | Pressemelding
AQR Capital Management, LLC (“AQR”) today began accepting submissions for the seventh annual AQR Insight Award. The AQR Insight Award recognizes and rewards exceptional academic papers that have practical applications and offer original, intelligent approaches to issues in the investment world. Up to three papers share a $100,000 annual prize. Winners are chosen by the AQR Insight Award Committee, a panel of senior members of the firm, many of whom are leading academic finance experts from top universities. AQR will accept papers on any investment-related topic as long as they deliver clear, significant insights. Papers must not be published before October 1, 2017. The deadline for entries is November 1, 2017. The Committee will then narrow the finalists to five papers, and the authors of those papers will be invited to present their research to
ANA Announces New Online Content "IS JAPAN COOL? DOU"23.8.2017 15:00 | Pressemelding
Today, All Nippon Airways Co., Ltd. (ANA), Japan’s largest and only 5-Star airline, is proud to announce the launch of its new online content “IS JAPAN COOL? DOU,” which illustrates traditional Japanese culture through the use of cutting-edge technology. This content can be seen on “IS JAPAN COOL?,” a website that promotes tourist destinations and popular Japanese cultures to the world. This Smart News Release features multimedia. View the full release here: http://www.businesswire.com/news/home/20170823005024/en/ "IS JAPAN COOL? DOU" TOP (Graphic: Business Wire) While Japan is widely known for its unique pop culture, “IS JAPAN COOL?,” which launched in 2012, has put much of its focus on promoting Japan’s modern culture. As the number of tourists visiting Japan exceeded 24 million people as of 2016, the project aims to provide a deeper understa
Emailage Receives $10 Million Growth Equity Investment to Accelerate Global Expansion23.8.2017 14:00 | Pressemelding
Emailage, the leading provider of global fraud prevention and identity verification using email address scoring, today announced that it has received a $10 million growth equity investment. Anthos Capital led the investment, with participation from Radian Capital, Wipro Ventures, Mucker Capital and Tallwave Capital. Emailage will use the funding to expand existing partnerships, further advance its powerful email address-based predictive scoring system, and accelerate growth in North America, EMEA, LATAM and other key markets. “This investment will allow us to continue our rapid growth, enhance our leadership position in the online fraud detection market and deliver significant fraud prevention capabilities to businesses around the world,” said Emailage CEO Rei Carvalho. Emailage’s Software-as-a-Service solution delivers powerful, real-time risk intelligence by leveraging the
Westinghouse to Provide Fuel to PSEG’s Salem Nuclear Generating Station Through Continued Partnership23.8.2017 12:15 | Pressemelding
Westinghouse Electric Company today announced that it has signed a nuclear fuel contract extension with PSEG, a major supplier of nuclear power in New Jersey, to continue providing fuel assemblies for both units at the Salem Nuclear Generating Station. “Westinghouse has been the single-source fuel provider for PSEG’s Salem plant since its start of operations more than 40 years ago, and we are pleased to continue to support this important and long-standing customer through the delivery of safe, reliable high-performance fuel,” said David Howell, president, Americas Region, and chief growth officer at Westinghouse. “This continued partnership is recognition of our reliable fuel performance and confirmation of the important trust PSEG has in Westinghouse.” Under the terms of the contract, Westinghouse will deliver its 17x17 Robust Fuel Assemblies, known as RFA-2. The design of
GN Hearing Announces Availability of Rechargeable Solution for the Recently Launched ReSound LiNX 3D23.8.2017 12:00 | Pressemelding
GN Hearing introduces a rechargeable battery option for the revolutionary ReSound LiNX 3D hearing aids. Available in North America and other major markets from September 1, the rechargeable battery solution gives ReSound users even more options to choose from. The rechargeable option is also available for Beltone Trust in North America, and from September 1 this will be extended to other major markets. This Smart News Release features multimedia. View the full release here: http://www.businesswire.com/news/home/20170823005211/en/ GN Hearing has made a rechargeable battery option available for the revolutionary ReSound LiNX 3D hearing aids. (Photo: Business Wire) ReSound LiNX 3D Rechargeable – More Than Just Another Rechargeable Hearing Aid The rechargeable battery option is made available based on a deep understanding of user expectations
I vårt presserom finner du alle våre siste saker, kontaktpersoner, bilder, dokumenter og annen relevant informasjon om oss.Besøk vårt presserom