Aortic Valve Disease

WASHINGTON, Oct. 31, 2024 /PRNewswire/ -- Jenscare Scientific Co., Ltd. ("Jenscare" or the "Company") (HKEX: 9877), an innovative medical device company dedicated to interventional treatment for structural heart diseases with TTVR breakthroughs, has just released the 1-year outcome of LuX-Valve Plus TRAVEL II study at 2024 Transcatheter Cardiovascular Therapeutics Conference (TCT 2024) on October 29th in Washington, D.C., U.S.. TRAVEL II study results showed that LuX-Valve Plus system is safe and effective in achieving short delivery times, low composite event rates, significant TR reduction and improvement in functional and QoL (quality of life) metrics at 1 year. TRAVEL II aims to evaluate the long-term safety and efficacy of LuX-Valve Plus in the application on patients with severe tricuspid regurgitation and high surgical risk. The clinical trial enrolled 96 patients from 15 centers in China. The average age of the patients was 71.35 years old with an average STS score of 9.09%. 37.5% of the patients had prior left heart valve surgery/intervention, and 15.63% of them had pacemaker/ICD implanted before. Patients were combined with multi other comorbidities, which formed a poor baseline and increased the risks of surgical treatment or difficulties of other interventional therapies. The results showed that the device success rate was about 97%, and the average device operation time was around 35.56 minutes. The safety indicators showed that the incidence of composite events remained low at 12.50%. Incidence of myocardial infarction, acute liver failure, cardiovascular injury requiring surgical intervention, life-threatening hemorrhage were all 0.00%. All-cause mortality was only 4.17%. Incidence of acute renal failure, severe paravalvular leakage, and conversion to surgical tricuspid valve replacement or tricuspid valvuloplasty were 1.04%, 2.08%, and 3.13% respectively. Incidence of new onset degree III AVB requiring permanent pacemaker implantation was only 2.08%. The efficacy indicators showed that the TR grade, NYHA classification, and QoL improved significantly. At 1 year, 95.30% of patients showed no moderate or above tricuspid regurgitation (TR). In terms of NYHA cardiac function improvement, 85% of patients improved from pre-procedure NYHA class III/IV to class I/II. In terms of QoL, patients increased their Kansas City Cardiomyopathy Questionnaire (KCCQ) averaging score by 21 points. The results indicate that the cardiac function and QoL of patients improved continuously. Professor Juan F. Granada concluded that LuX-Valve Plus system is a versatile TTVR device that does not depend on radial force for anchoring. Its innovative design (ventricular septal anchor & leaflet-grasping clips) provides optional mechanisms for anchoring and stability. The multicenter, TRAVEL II study showed that LuX-Valve Plus system is safe and effective in achieving short delivery times, low 1-year composite event rates, significant TR reduction and improvement in functional and QoL metrics at 1 year. During the conference period, a case report named "Post-Endocarditis TTVR with the LuX-Valve Plus System" from Clinic Barcelona was shared as well. A 59 year old male patient with previous OH abuse, obesity, type A hepatitis, permanent atrial fibrillation and tricuspid endocarditis complicated with tricuspid regurgitation, right heart failure, pulmonary septic embolism and pulmonary empyema requiring long stay at ICU. Dr. Omar Abdul-Jawad Altisent introduced that the team decided to apply LuX-Valve Plus system after processing the Barcelona Hospital Clinic Algorithm to treat TR due to the high risk for open heart surgery and unfavorable anatomy for repairment (significant dilation of the tricuspid annulus plus a significant gap). The 30-day follow-up showed an improvement in all functional and QoL parameters. In the end, he concluded that this is the first case of a successful percutaneous tricuspid valve replacement in a patient with previous endocarditis, significant aseptic vegetations and advanced right heart failure. The specific design of the LuX-Valve Plus system, including a septal attachment to increase valve stability, various sizes available, along with the flexible properties of the prothesis which permits preservation of the RV function makes this device feasible for most of tricuspid anatomies even at advanced states of the disease or valve destruction. There were some other interesting sharing of LuX-Valve Plus in many other sessions, such as "Transcatheter tricuspid valve replacement for a patient with torrential tricuspid regurgitation and pacemaker leads", "One-Year Clinical Outcomes of T-TEER versus TTVR among High-Risk Patients with Symptomatic Tricuspid Regurgitation: A Propensity-Score Matched Analysis" etc.. LuX-Valve Plus has gained high attention and recognition after its appearance in New York Valves 2024 earlier this year. Additional studies in Europe and the U.S. using the LuX-Valve Plus system are underway, and more clinical results are expected to be released in the future. The Company is continuously advancing the global application of LuX-Valve series system to help more TR patients. About LuX-Valve Plus LuX-Valve Plus, the proprietary TTVR system, is designed for patients with severe tricuspid regurgitation (TR) and high surgical risk. LuX-Valve Plus breaks through multiple technical difficulties in tricuspid valve interventional therapy. With the design of innovative "interventricular septum anchoring" and "leakproof self-adaptive braided ring", which enables non-radial anchoring of the valve implant and tend to effectively prevent AV Block. LuX-Valve series product is designated by the FDA as a breakthrough device, is enrolled in the Total Product Life Cycle Advisory Program (TAP) pilot of the FDA and is selected for the Expert Panel Scientific Advice Pilot by the EMA. As of the latest update, over 600 implantation cases have been completed worldwide with the LuX-Valve series products, and the longest follow-up record has been over 6 years. About Jenscare Jenscare is an innovative medical device company, established in 2011. The Company has achieved a complete product layout of interventional treatment solutions for different types of structural heart diseases, including tricuspid valve disease, mitral valve disease, aortic valve disease and cardioembolic thrombi prevention. LuX-Valve series products, the core products, are innovative in the design concepts and treatment solutions. It is expected to become one of the first commercialized tricuspid valve replacement products in the world. SOURCE Jenscare Scientific Co., Ltd. WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

MARLBOROUGH, Mass., Aug. 27, 2024 /PRNewswire/ -- Boston Scientific Corporation (NYSE: BSX) today announced it has obtained CE mark for the ACURATE Prime™ Aortic Valve System, the newest transcatheter aortic valve replacement (TAVR) technology in the company's structural heart portfolio. The ACURATE Prime valve system is designed with several features to build upon the clinical performance of the ACURATE neo2™ platform including an additional valve size, which expands the treatment range to patients with a larger anatomy. Continue Reading Video: ACURATE Prime Aortic Valve System ACURATE Prime™ Aortic Valve System The new ACURATE Prime valve system is indicated to restore function and normal blood flow through a narrowed aortic valve in low, intermediate and high-risk patients with severe aortic stenosis. With a self-expanding, supra-annular design, this device has an enhanced frame that equalizes force across the valve for a stable fit against the native, diseased valve. It also offers physicians a redesigned deployment mechanism for highly accurate valve positioning to help ensure positive patient outcomes. "The introduction of the ACURATE Prime technology offers physicians a TAVR option designed for streamlined procedural preparation, improved performance in complex cases and simplified delivery for quick and controlled deployment," said Janar Sathananthan, M.D., chief medical officer, Interventional Cardiology Therapies, Boston Scientific. "Further, our clinical experience with the valve to date has shown the ability for precise positioning of the device in a broader population of patients, allowing more clinicians to consider this technology for treatment in challenging or larger heart structures." The ACURATE Prime valve system will now be available for the treatment of aortic annulus diameters between 20.5 and 29 mm. It will also carry through many of the design features and clinical outcomes demonstrated in global studies with the ACURATE neo2 platform, including low pacemaker and paravalvular leak rates,1,2 strong hemodynamic performance,1 as well as unrestricted coronary access for future procedures. "We are thrilled to offer physicians a new valve with meaningful improvements for the treatment of an increasing number of patients with aortic valve disease," said Lance Bates, senior vice president and president, Interventional Cardiology Therapies, Boston Scientific. "Built on the ACURATE valve platform, which has been implanted in nearly 80,000 patients globally to date, the ACURATE Prime valve system is engineered to improve long-term cardiac function and provide access for future treatment needs, thereby supporting the lifetime management of these patients." The company will initiate the launch of the ACURATE Prime valve system in Europe in the coming weeks. For more information on the system, visit . *In Europe, the ACURATE neo2™ Aortic Valve System and the ACURATE Prime™ Aortic Valve System are CE-marked. In the USA, the ACURATE neo2 Aortic Valve System and the ACURATE Prime Aortic Valve System are investigational devices and are restricted under federal law to investigational use only. Not available for sale. About Boston Scientific Boston Scientific transforms lives through innovative medical technologies that improve the health of patients around the world. As a global medical technology leader for more than 45 years, we advance science for life by providing a broad range of high-performance solutions that address unmet patient needs and reduce the cost of health care. Our portfolio of devices and therapies helps physicians diagnose and treat complex cardiovascular, respiratory, digestive, oncological, neurological and urological diseases and conditions. Learn more at and connect on LinkedIn and X, formerly Twitter. Cautionary Statement Regarding Forward-Looking Statements This press release contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934. Forward-looking statements may be identified by words like "anticipate," "expect," "project," "believe," "plan," "estimate," "intend" and similar words. These forward-looking statements are based on our beliefs, assumptions and estimates using information available to us at the time and are not intended to be guarantees of future events or performance. These forward-looking statements include, among other things, statements regarding our business plans and product performance and impact, and new and anticipated product approvals and launches. If our underlying assumptions turn out to be incorrect, or if certain risks or uncertainties materialize, actual results could vary materially from the expectations and projections expressed or implied by our forward-looking statements. These factors, in some cases, have affected and in the future (together with other factors) could affect our ability to implement our business strategy and may cause actual results to differ materially from those contemplated by the statements expressed in this press release. As a result, readers are cautioned not to place undue reliance on any of our forward-looking statements. Factors that may cause such differences include, among other things: future economic, competitive, reimbursement and regulatory conditions; manufacturing, distribution and supply chain disruptions and cost increases; variations in outcomes of ongoing and future clinical trials and market studies; new product introductions; demographic trends; intellectual property; litigation; financial market conditions; and future business decisions made by us and our competitors. All of these factors are difficult or impossible to predict accurately and many of them are beyond our control. For a further list and description of these and other important risks and uncertainties that may affect our future operations, see Part I, Item 1A – Risk Factors in our most recent Annual Report on Form 10-K filed with the Securities and Exchange Commission, which we may update in Part II, Item 1A – Risk Factors in Quarterly Reports on Form 10-Q we have filed or will file hereafter. We disclaim any intention or obligation to publicly update or revise any forward-looking statements to reflect any change in our expectations or in events, conditions or circumstances on which those expectations may be based, or that may affect the likelihood that actual results will differ from those contained in the forward-looking statements, except as required by law. This cautionary statement is applicable to all forward-looking statements contained in this document. CONTACTS: Angela Mineo Media Relations +1 (763) 955-8325 [email protected] Jon Monson Investor Relations +1 (508) 683-5450 [email protected] 1 Rück A, Kim WK, Abdel-Wahab M, et al. The Early neo2 Registry: Transcatheter Aortic Valve Implantation with ACURATE neo2 in a European Population. J Am Heart Assoc. 2023 Aug;12(15):e029464. 2 Kim WK, Tamburino C, Möllmann H, et al. Clinical outcomes of the ACURATE neo2 transcatheter heart valve: a prospective, multicenter, observational, post-market surveillance study. EuroIntervention. 2023 May 12;19(1):83-92. SOURCE Boston Scientific Corporation

IRVINE, Calif.--( BUSINESS WIRE )--Edwards Lifesciences (NYSE: EW) today announced investments that reflect the company’s deep commitment to advancing patient care through structural heart innovation, addressing large unmet patient needs and supporting sustainable long-term growth. Edwards has entered into an agreement to acquire JenaValve Technology , a pioneer in the transcatheter treatment of aortic regurgitation (AR), a deadly disease that impacts a significant and growing population and is largely untreated today. JenaValve presented positive results of its U.S. pivotal trial for the treatment of symptomatic, severe AR in high-risk patients late last year. As the pioneer in valve innovation for more than 60 years, Edwards believes it is uniquely positioned to lead this next frontier of aortic valve disease treatment. Edwards anticipates FDA approval of the JenaValve Trilogy Heart Valve System in late 2025, which will represent the first approved therapy for patients suffering from AR. Building on an investment made in 2016, Edwards has exercised its option to acquire Endotronix , a leader in heart failure (HF) management solutions. Many structural heart patients Edwards serves today also suffer from HF with limited options. This acquisition will expand Edwards’ structural heart portfolio into a new therapeutic area to address the large unmet needs of patients suffering from HF. Last month, Endotronix received FDA approval for Cordella, an implantable pulmonary artery pressure sensor allowing early, targeted therapeutic intervention. A CMS national coverage determination is expected in early 2025. “ These acquisitions expand our opportunities to address the unmet needs of aortic regurgitation and heart failure patients around the world,” said Bernard Zovighian, Edwards’ CEO. “ We are pleased to enter these structural heart therapeutic areas with innovation, world-class science and clinical evidence to provide access to life-saving technologies for patients around the world.” Edwards anticipates these investments will strengthen its leadership in structural heart innovation and represent long-term growth opportunities. Edwards expects minimal revenue contribution from these acquisitions in 2025. The aggregate upfront purchase price for these strategic investments is approximately $1.2 billion. The acquisitions are subject to the satisfaction of certain closing conditions, including the receipt of required antitrust and foreign investment approvals. About Edwards Lifesciences Edwards Lifesciences is the global leader of patient-focused innovations for structural heart disease and critical care monitoring. We are driven by a passion for patients, dedicated to improving and enhancing lives through partnerships with clinicians and stakeholders across the global healthcare landscape. For more information, visit www.edwards.com and follow us on Facebook, Instagram, LinkedIn, X and YouTube. This news release includes forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. We intend the forward-looking statements contained in this press release to be covered by the safe harbor provisions of such Acts. These forward-looking statements can sometimes be identified by the use of forward-looking words, such as “may,” “might,” “believe,” “will,” “expect,” “project,” “estimate,” “should,” “anticipate,” “plan,” “goal,” “continue,” “seek,” “intend,” “optimistic,” “aspire,” “confident” and other forms of these words and include, but are not limited to, statements made by Mr. Zovighian and statements regarding our expected continued performance of Edwards; performance of the Edwards, JenaValve or Endotronix technologies; product and therapy benefits; patient access and outcomes; size of treatable population; leading position; growth opportunities; unmet needs in structural heart, aortic regurgitation, and heart failure therapeutic areas; probability of approval by the FDA and in the anticipating timeline; probability of a positive NCD by the CMS and in the anticipated timeline; synergies between the technologies, business, and operations of each of JenaValve and Endotronix and Edwards’ technologies, products, portfolio, expertise, and operations; ability to leverage the technology or innovation from these acquisitions or cause or ensure accelerated access to life-saving technologies for patients or development of novel technologies as a result of these acquisitions; commitment to expand opportunities in structural heart innovation, address large unmet patient needs, and support sustainable long-term growth; objective to expand Edwards’ portfolio into new structural heart therapeutic areas; opportunities and revenue return on these acquisitions and their contribution to Edwards’ growth and performance, as well as the expectations on timing of such returns and contributions; therapy approval pipeline for patients suffering from AR; probability of the closing of the two acquisitions; other objectives and expectations; and other statements that are not historical facts. Forward-looking statements are based on estimates and assumptions made by management of the company and are believed to be reasonable, though they are inherently uncertain and difficult to predict. Our forward-looking statements speak only as of the date on which they are made, and we do not undertake any obligation to update any forward-looking statement to reflect events or circumstances after the date of the statement. Investors are cautioned not to unduly rely on such forward-looking statements. Forward-looking statements involve risks and uncertainties that could cause actual results or experience to differ materially from that expressed or implied by the forward-looking statements. Factors that could cause actual results or experience to differ materially from that expressed or implied by the forward-looking statements include, but are not limited to: (i) Edwards may be unable to close the acquisitions of each of JenaValve and Endotronix, which may materially and adversely affect Edwards’ business and the price of Edwards’ common stock; (ii) the occurrence of any event, change or other circumstance that could cause Edwards to abandon the acquisitions of either or both of JenaValve and Endotronix; (iii) risks related to disruption of management’s attention from Edwards’ ongoing business operations; (iv) the effect of the announcement or the pendency of the acquisitions on Edwards’ relationships with its customers, operating results and business generally; (v) potential significant transaction costs associated with either or both acquisitions; (vi) the outcome of any legal proceedings or regulatory actions to the extent initiated against Edwards or others related to either or both acquisitions; (vii) the ability of Edwards to execute on its strategy and achieve its goals and other expectations after the closing of either or both acquisitions; (viii) legal, regulatory, tax and economic developments affecting Edwards’ business; (ix) the unpredictability and severity of catastrophic events, including, but not limited to, acts of terrorism, outbreak of war or hostilities or current or future pandemics or epidemics, as well as Edwards’ response to any of the aforementioned factors; and (x) other risks detailed in Edwards’ filings with the SEC, which may be found at edwards.com. 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