LivaNova Presents New Data at European Association for Cardio-Thoracic Surgery Annual Meeting Demonstrating Benefits of Perceval Sutureless Valve
LivaNova PLC (NASDAQ:LIVN) a market-leading medical technology and innovation company, today announced new data from the Perceval® Sutureless Implant Versus Standard-Aortic Valve Replacement (PERSIST-AVR) clinical study and the Sorin Universal Registry on Aortic Valve Replacement (SURE-AVR). Results from a PERSIST-AVR sub-analysis demonstrated better clinical outcomes for patients with aortic valve stenosis who received the Perceval sutureless surgical aortic valve via minimally invasive cardiac surgery (MICS) than patients who received a stented valve through the same access. Data from a SURE-AVR sub-analysis further supported positive findings for Perceval using MICS or full sternotomy. The results were presented during a series of presentations at the 34th Annual Meeting of the European Association for Cardio-Thoracic Surgery (EACTS).
“The new PERSIST-AVR data presented at EACTS highlight that the Perceval valve is a reliable and essential technology to be considered as part of any comprehensive valve program and an essential complement to transcatheter technology. Due to its innovative sutureless design, Perceval facilitates minimally invasive cardiac surgery and offers these patients significant benefits such as decreased procedure times, fewer complications and fewer re-hospitalizations,” said Dr. Brian Duncan, Vice President of Medical Affairs at LivaNova. “New findings from SURE-AVR presented at EACTS further demonstrate important benefits from innovation in our next-generation Perceval Plus valve resulting in improved patient outcomes.”
PERSIST-AVR Clinical Study
The prospective, randomized, multi-center, international PERSIST-AVR study assessed the safety, efficacy and noninferiority of the sutureless Perceval valve compared with standard stented bio-prostheses using conventional or mini-sternotomy. A total of 910 patients with severe symptomatic aortic valve stenosis were enrolled in 12 countries. A total of 578 patients underwent isolated aortic valve replacement (AVR).
PERSIST-AVR results presented during EACTS showed that patients who received Perceval during a mini-sternotomy in isolated AVR had a significantly lower incidence of:
- Major adverse cardiovascular and cerebrovascular events (MACCEs) – 5.2% of the Perceval group versus 10.8% of the stented valve group
- New onset of atrial fibrillation – 4.2% in the Perceval group versus 11.4% in the stented valve group
- Stroke – 1% in the Perceval group versus 5.4% in the stented valve group
Prof. Roberto Lorusso, Full Professor in the Cardio-Thoracic Surgery Department of the Maastricht University Medical Centre, the Netherlands, presented the new PERSIST-AVR data. “In this sub-cohort, Perceval significantly reduced MACCEs at one-year follow up, reduced re-hospitalization days and demonstrated a 30% reduction in cross-clamping time, providing patients with a minimally invasive and less traumatic surgical solution compared to stented valves,” said Prof. Lorusso. “This data is encouraging as it provides further evidence that Perceval facilitates MICS and simplifies complex procedures when time matters.”
The ongoing, prospective, international SURE-AVR registry used real-world data to compare outcomes of patients who received Perceval using MICS or conventional full sternotomy. SURE-AVR is collecting data on outcomes from patients at 60 sites in 18 countries. One sub-analysis presented at EACTS was based on data from 980 isolated AVR patients at 52 international institutions. A total of 676 patients underwent MICS and 304 received a full sternotomy. Results showed that Perceval enables MICS, providing a rate of successful implantation similar to that of full sternotomy.
Dr. Marco Solinas, Cardiac Surgeon, G. Monasterio Foundation Heart Hospital, Massa, Italy, presented the SURE-AVR registry data at EACTS. “These real-life results from an international registry showed that implanting Perceval during MICS resulted in significantly shorter ICU stays than a complete sternotomy and that Perceval in isolated AVR is associated with early- and mid-term good clinical and hemodynamic results both in MICS and full sternotomy,” said Dr. Solinas. “Furthermore, Perceval in MICS results in comparable cross-clamping time to full-sternotomy, eliminating the main concern for broader MICS adoption and reinforcing the role of Perceval as a MICS enabler.”
Analysis of the SURE-AVR registry also provided initial real-world clinical performance data of the Perceval Plus™ valve. Perceval Plus is designed to enhance the Perceval platform by decreasing permanent pacemaker implantation (PPI) rates and improving durability, further advancing the treatment of aortic valve stenosis. Of patients enrolled in SURE-AVR between March 2011 and February 2020, 1,374 underwent AVR with the Perceval valve and 121 with the Perceval Plus valve.
PD Dr. Maximilian Scherner, Department of Cardiac and Thoracic Surgery, University Hospital Magdeburg, Germany, presented data from SURE-AVR related to Perceval Plus during EACTS. “Perceval Plus further improved patient outcomes with reduced pacemaker implantation rates compared to Perceval, while both valves were associated with overall low morbidity and mortality,” said PD Dr. Scherner. “Changes to the design did not impact the sealing at the annulus, and both Perceval and Perceval Plus demonstrated a low percentage of paravalvular regurgitation.”
LivaNova received CE Mark for Perceval in 2011 followed by U.S. Food and Drug Administration approval in 2016. The company received CE Mark for Perceval Plus in 2018. To date, more than 50,000 patients worldwide have been treated with the Perceval valve. To learn more about Perceval and Perceval Plus, visit www.livanova.com.
LivaNova PLC is a global medical technology and innovation company built on nearly five decades of experience and a relentless commitment to provide hope for patients and their families through innovative medical technologies, delivering life-changing improvements for both the Head and Heart. Headquartered in London, LivaNova employs approximately 4,000 employees and has a presence in more than 100 countries for the benefit of patients, healthcare professionals and healthcare systems worldwide. LivaNova operates as two businesses: Cardiovascular and Neuromodulation, with operating headquarters in Mirandola (Italy) and Houston (U.S.), respectively.
For more information, please visit www.livanova.com.
Safe Harbor Statement
This news release contains “forward-looking statements” concerning our goals, beliefs, expectations, strategies, objectives, plans and underlying assumptions and other statements that are not necessarily based on historical facts. These statements include, but are not limited to, statements regarding Perceval, Perceval Plus and findings from the PERSIST-AVR clinical study and SURE-AVR registry. Actual results may differ materially from those indicated in our forward-looking statements as a result of various factors, including those factors set forth in Item 1A of our Annual Report on Form 10-K for the year ended December 31, 2019, as supplemented by any risk factors contained in our Quarterly Reports on Form 10-Q and our Current Reports on Form 8-K. We undertake no obligation to update the information contained in this press release to reflect subsequently occurring events or circumstances.
LivaNova PLC Media Contact
Deanna Wilke, +1 (281) 727-2764
VP, Corporate Communications
About Business Wire
For more than 50 years, Business Wire has been the global leader in press release distribution and regulatory disclosure.
Subscribe to releases from Business Wire
Subscribe to all the latest releases from Business Wire by registering your e-mail address below. You can unsubscribe at any time.
Latest releases from Business Wire
PMI Announces Medicago to Supply Up to 76 Million Doses of Its Plant-Derived COVID-19 Vaccine Candidate23.10.2020 21:00:00 EEST | Press release
Since 2008, Philip Morris Investments B.V. (PMIBV), a subsidiary of Philip Morris International (PMI) (NYSE: PM), has been a shareholder of Medicago (in which it currently holds an approximately one-third equity stake) and has supported Medicago’s innovative plant-derived research and development focused on vaccines. The investment is consistent with PMI’s own efforts to leverage science and innovation. Japan-based Mitsubishi Tanabe Pharma Corporation (MTPC) is the majority shareholder and PMIBV’s partner in Medicago. Among other things, PMIBV and MTPC will contribute additional funding to support Medicago’s efforts to develop a COVID-19 vaccine candidate. Medicago, a biopharmaceutical company headquartered in Quebec City, announced that it reached an agreement with Public Services and Procurement Canada (PSPC) to supply up to 76 million doses of its vaccine candidate for COVID-19, subject to Health Canada approval. Innovation, Science & Economic Development (ISED), another department
Fujikura Enters 5G mmWave Infrastructure Market With the Introduction of Industry’s Highest Performance, and Low Power Consumption Phased Array Antenna Module (PAAM)23.10.2020 11:00:00 EEST | Press release
Fujikura Ltd. (TOKYO:5803) (President & CEO: Masahiko Ito) today announced the introduction of industry’s most advanced and highly integrated Phased Array Antenna Module (PAAM) for 5G mmWave operating in 3GPP bands n257 (28 GHz), n258 (26 GHz) and n261 (27 GHz). The Fujikura PAAM is the industry’s highest performance PAAM targeting indoor and outdoor applications such as 5G mmWave Fixed Wireless Access (FWA), 5G mmWave Mobile Wireless Access (MWA), 5G mmWave wireless backhaul, and other emerging applications. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20201023005099/en/ Fig.1 Block diagram of Fujikura PAAM. (Graphic: Business Wire) Key Differentiating Features of the Fujikura PAAM The Fujikura PAAM is a high performance phased array antenna module with a novel integrated antenna, and supports concurrent dual polarized beams in both transmission and reception (Fig.1). The PAAM integrates best-in-class mmWave-ICs developed i
VAAST Bikes Now Available in Europe23.10.2020 10:02:00 EEST | Press release
VAAST Bikes, a forward-thinking bicycle manufacturer known for its innovative Allite® Super Magnesium™ frames, has signed an agreement with German cycling-specialist retailer giant Internetstores (Fahrrad.de/Brügelmann.de/Bikester). Two of VAAST’s key bicycle models – including the gravel-ready all-road A/1 bike, and the urban U/1 – are now stocked at Internetstores’ eCommerce sites. Both VAAST models will be available to order online for delivery in fourteen locations across Europe via Fahrrad.de/Brügelmann.de in Germany and the partner site Bikester in 13 countries, including the UK, France, the Netherlands, Belgium, Switzerland, Austria, Poland, Denmark, Italy, Sweden, Norway, Finland and Spain. Customers in Germany can benefit from personal service in Fahrrad.de’s five stores and 190 local service partners, while eCommerce customers Europe-wide will be able to receive their new VAAST bicycle within just days of ordering online. VAAST’s unique position as the only bicycle manufactur
Mitsubishi Chemical Holdings Corporation: Notice Regarding Change in Representative Corporate Executive Officers23.10.2020 09:40:00 EEST | Press release
Mitsubishi Chemical Holdings Corporation (“MCHC”) (TOKYO: 4188) announced that, at the meeting of its Board of Directors held today, it resolved change of representative corporate executive officers as outlined below. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20201022006285/en/ Jean-Marc Gilson (Photo: Business Wire) 1. Change in Representative Corporate Executive Officers (Appointed) Name: Jean-Marc Gilson Title: Representative Corporate Executive Officer President and Chief Executive Officer (Retiring) Name: Hitoshi Ochi Title: Representative Corporate Executive Officer President and Chief Executive Officer 2. Biographical Sketch of New Representative Corporate Executive Officer Refer to the appendix 3. Scheduled Date of Appointment April 1, 2021 4. Reason for the Change MCHC converted to a company with a nominating committee, etc. in June 2015. Since then, the Nominating Committee has carried out preparations to proper
MYAH Wins Prestigious Silmo D’Or Award23.10.2020 08:00:00 EEST | Press release
Topcon Healthcare, a leading provider of medical devices and software solutions for the global eye care community, announced today that its MYAH myopia and dry eye management device has won the 2020 Silmo D’Or Award in the Material/Equipment category. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20201022005242/en/ Topcon Healthcare announced today that its MYAH myopia and dry eye management device has won the 2020 Silmo D’Or Award. (Photo: Business Wire) The Silmo D’Or Awards are presented each year to recognize creativity in optical product design, innovation and technology. This year marked the 27th annual awards ceremony, which was held virtually and live streamed online on Saturday, October 3rd. The award committee was proud to recognize forward-thinking companies who have continued to launch products and propel the industry forward despite the global pandemic. MYAH came out on top in the Material/Equipment category and
ABB: Q3 2020 Results23.10.2020 07:46:00 EEST | Press release
“Third quarter revenues in all business areas were still dampened due to the impact of COVID-19, although a strong recovery in China and ongoing cost mitigation efforts supported a strong underlying performance. On the upside, the integration of GEIS and turnaround of Installation Products in Electrification is starting to bear fruit and Motion is performing robustly. Robotics and Industrial Automation, on the other hand, are taking more time to recover,” said Björn Rosengren, CEO of ABB. “We are pushing ahead with the decentralization of the group and the ongoing review of our portfolio, while carrying out our share buyback program as planned. We look forward to presenting further details on our strategic progress at our Capital Markets Day on November 19.” KEY FIGURES CHANGE CHANGE ($ millions, unless otherwise indicated) Q3 2020 Q3 2019 US$ Comparable 9M 2020 9M 2019 US$ Comparable Orders 6,109 6,688 -9% -8% 19,509 21,702 -10% -7% Revenues 6,582 6,892 -4% -4% 18,952 20,910 -9% -7% I
In our pressroom you can read all our latest releases, find our press contacts, images, documents and other relevant information about us.Visit our pressroom