Mitral Valve Stenosis

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

Innovalve's approach collects and twists the mitral valve's tendon-like chordae—also known as the heart strings—to form a tight seal for the replacement implant. After previously backing the startup, Edwards Lifesciences is exercising its option to acquire Innovalve and its mitral valve replacement implant. In an SEC filing, Edwards said it plans to pay about $300 million in cash upfront, with the deal slated to close before the end of this year. According to Innovalve, the company has received an FDA green light to conduct human feasibility trials in the U.S. using its Innostay system. The transcatheter implant is designed to form a tight seal within the mitral valve regardless of its natural shape, by twisting together and holding shut the valve’s tendon-like cords before deploying the prosthetic implant—a device that literally tugs at the heartstrings. “Building on our learnings of the complexity of mitral disease, we know there is a need for a differentiated range of therapies for these patients,” Edwards’ transcatheter mitral and tricuspid therapy group leader, Daveen Chopra, said in a statement. “Edwards’ SAPIEN M3 remains on track to become the first approved transfemoral TMVR system in Europe by the end of 2025,” Chopra added. “We believe the Innovalve technologies, paired with Edwards’ deep mitral expertise, will enable a TMVR platform that will expand the treatable population.” Edwards first invested in Innovalve Bio Medical in 2017, as it was being spun out of Sheba Medical Center in Tel Aviv, Israel. Since then, Edwards said the company has shown “promising early clinical experience.” The heart valve maker last week also invested in (PDF) the France-based mitral valve designer Affluent Medical, including 15 million euros to obtain options for its adjustable mitral ring and open-surgery valve implant, as well as an equity stake in the company.

IRVINE, Calif.--( BUSINESS WIRE )--Edwards Lifesciences (NYSE: EW) today announced it has exercised its option to acquire Innovalve Bio Medical Ltd., an early-stage transcatheter mitral valve replacement (TMVR) company, following its initial investment in 2017. Since that time, Innovalve has demonstrated progress in its program with promising early clinical experience. Combined with Edwards’ existing mitral innovations, the acquisition enhances the company’s TMVR technologies to address large unmet structural heart patient needs and support sustainable long-term growth. Innovalve will join the transcatheter mitral and tricuspid therapies (TMTT) product group, led by corporate vice president, Daveen Chopra. “ Building on our learnings of the complexity of mitral disease, we know there is a need for a differentiated range of therapies for these patients,” said Chopra. “ Edwards’ SAPIEN M3 remains on track to become the first approved transfemoral TMVR system in Europe by the end of 2025. We believe the Innovalve technologies, paired with Edwards’ deep mitral expertise, will enable a TMVR platform that will expand the treatable population.” Edwards is developing a portfolio of transcatheter repair and replacement therapies designed to address mitral and tricuspid valve diseases. The company is committed to transforming the treatment of mitral and tricuspid patients, supported by a robust body of clinical evidence. The acquisition is expected to close by the end of 2024. 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 Proxy Statement 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. Chopra and statements regarding expected technology performance, product and therapy benefits, patient outcomes, treatable population, probability of approval by government authorities in Europe, performance of Innovalve’s technology as a basis for or in support of a TMVR platform, synergy between Innovalve’s technology and products and Edwards’ expertise, products, and operations, Edwards’ commitment to developing a portfolio of transcatheter repair and replacement therapies and to expanding or transforming patients’ treatments, 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 acquisition of Innovalve in a timely manner or at all, which may materially and adversely affect Edwards’ business and the price of Edward’ common stock; (ii) uncertainty as to the timing of closing of the acquisition of Innovalve; (iii) the occurrence of any event, change or other circumstance that could cause Edwards to abandon the acquisition of Innovalve; (iv) risks related to disruption of management’s attention from Edwards’ ongoing business operations; (v) the effect of the announcement or the pendency of the acquisition of Innovalve on Edwards’ relationships with its customers, operating results and business generally; (vi) potential significant transaction costs associated with the acquisition of Innovalve; (vii) the outcome of any legal proceedings or regulatory actions to the extent initiated against Edwards or others related to the acquisition of Innovalve; (viii) the ability of Edwards to execute on its strategy and achieve its goals and other expectations after the closing of the acquisition of Innovalve; (ix) legal, regulatory, tax and economic developments affecting Edwards’ business; (x) 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 (xi) other risks detailed in Edwards’ filings with the SEC, which may be found at edwards.com. Edwards, Edwards Lifesciences, the stylized E logo, Edwards SAPIEN, Edwards SAPIEN M3, SAPIEN, and SAPIEN M3 are trademarks of Edwards Lifesciences Corporation. All other trademarks are the property of their respective owners.