Procedure-Related Techniques and Care Pathways from the OPTIMIZE PRO Clinical Study Show Promising Early Outcomes for Patients Implanted with the Medtronic Evolut TAVR System

Medtronic plc (NYSE:MDT), the global leader in medical technology, today announced results from an interim analysis of the first 171 patients (including 71 roll-ins) treated in the OPTIMIZE PRO clinical study. The post-market, prospective, multi-center study is evaluating procedural outcomes (including pacemaker rate) associated with procedure-related techniques and post-procedure TAVR care pathways when using the self-expanding, supra-annular Evolut™ PRO and PRO+ TAVR systems in patients with symptomatic severe aortic stenosis. The interim data was presented virtually at the Society for Cardiovascular Angiography and Interventions (SCAI) 2021 Scientific Sessions.

Study investigators utilized several procedural approaches with the Evolut TAVR system in the study, including the "cusp overlap technique," which is designed to help implanters assess and achieve the target implant depth in an effort to reduce interaction with the conduction system.

At 30 days, excellent safety outcomes were observed with zero death or disabling stroke and a low pacemaker rate (8.8%). Additionally, the Evolut platform showed excellent hemodynamic (blood flow) performance with low mean gradients (8.1 mm Hg) and low rates of residual total aortic regurgitation with the majority of subjects having none/trace (80.4%), and the rest mild (19.6%) at discharge. Patients also experienced an expedited discharge with a median hospital length of stay of one day.

The OPTIMIZE PRO study utilizes a TAVR care pathway to evaluate common practices and shared experiences such as conscious sedation and early mobilization. A conduction disturbance pathway evaluates efficiencies and heart team considerations for monitoring and managing patients with conduction disturbance who might be considered for a pacemaker post TAVR.

"The evolution of TAVR requires that we refine aspects of the procedure and post-procedure care pathways to improve patient outcomes," said Kendra Grubb , M.D., surgical director of the Structural Heart and Valve Center at Emory Healthcare in Atlanta , and co-principal investigator in the OPTIMIZE PRO study who presented the data at the meeting. "Interim results from this study demonstrate improvements, like low pacemaker rates and next-day discharge, and are supportive of the hypothesis that the cusp overlap technique can improve patient care."

The OPTIMIZE PRO study is being conducted at 46 study sites in the U.S. and Canada and up to 15 sites in Europe . The primary endpoint includes the rate of all-cause mortality or all-stroke at 30 days with secondary endpoints of discharge time, percent of patients with more than moderate aortic regurgitation, and the rate of pacemaker implant for new-onset or worsening conduction disturbance at 30 days. The study will also evaluate rehospitalization rates and discharge time at 30 days and one year.

"As a leader in transcatheter valves therapies, we are committed to helping implanting centers standardize and further refine their TAVR care pathways to improve patient outcomes," said Nina Goodheart , president of the Structural Heart & Aortic business, which is part of the Cardiovascular Portfolio at Medtronic. "In addition to helping us better understand the site-driven dynamics around conduction disturbance post-TAVR, the study also allows us to generate additional evidence around the Evolut PRO and PRO+ system's advanced sealing skirt and its impact on paravalvular leak."

The Evolut TAVR platform, including the Evolut™ R, Evolut™ PRO and Evolut PRO+ TAVR System, is indicated for symptomatic severe aortic stenosis patients across all risk categories (extreme, high, intermediate and low) in the U.S. The Evolut PRO and PRO+ valves feature an outer tissue wrap that adds surface area contact between the valve and the native aortic annulus to further advance valve sealing.

In collaboration with leading clinicians, researchers and scientists worldwide, Medtronic offers the broadest range of innovative medical technology for the interventional and surgical treatment of cardiovascular disease and cardiac arrhythmias. The company strives to offer products and services that deliver clinical and economic value to healthcare consumers and providers around the world.

About Medtronic
Medtronic plc ( www.medtronic.com ), headquartered in Dublin, Ireland , is among the world's largest medical technology, services and solutions companies – alleviating pain, restoring health and extending life for millions of people around the world. Medtronic employs more than 90,000 people worldwide, serving physicians, hospitals and patients in more than 150 countries. The company is focused on collaborating with stakeholders around the world to take healthcare Further, Together.

Any forward-looking statements are subject to risks and uncertainties such as those described in Medtronic's periodic reports on file with the Securities and Exchange Commission. Actual results may differ materially from anticipated results.  

Contacts:




Joey Lomicky

Ryan Weispfenning

Public Relations

Investor Relations

+1-763-526-2494

+1-763-505-4626

Medtronic plc (PRNewsfoto/Medtronic plc)

Cision View original content to download multimedia: https://www.prnewswire.com/news-releases/procedure-related-techniques-and-care-pathways-from-the-optimize-pro-clinical-study-show-promising-early-outcomes-for-patients-implanted-with-the-medtronic-evolut-tavr-system-301278580.html

SOURCE Medtronic plc

Cision View original content to download multimedia: https://www.newswire.ca/en/releases/archive/April2021/28/c5659.html

News Provided by Canada Newswire via QuoteMedia

The Conversation (0)

Bausch Health Responds to Rumors of a Potential Sale of Bausch + Lomb

Bausch Health Companies Inc. (NYSE:BHC)(TSX:BHC) (the "Company" or "Bausch Health"), a global, diversified pharmaceutical company enriching lives through a relentless drive to deliver better health outcomes, issued the following statement in response to a request from the Canadian Investment Regulatory Organization (CIRO

"As previously disclosed, the Company believes that completing the full separation of its subsidiary, Bausch + Lomb Corporation (NYSE/TSX: BLCO) ("Bausch + Lomb"), makes strategic sense. The Bausch Health Board of Directors authorized management and management of its subsidiary, Bausch + Lomb, to explore a potential sale, which is one of several options being considered to complete the separation. That process is ongoing. No decision has been reached to proceed with any particular transaction, and there can be no assurance that it will result in a transaction.

News Provided by ACCESSWIRE via QuoteMedia

Keep reading...Show less

Medtronic announces cash dividend for third quarter of fiscal year 2025

The board of directors of Medtronic plc (NYSE: MDT) on Thursday, December 5, 2024, approved the company's cash dividend for the third quarter of fiscal year 2025 of $0 .70 per ordinary share. This quarterly declaration is consistent with the dividend increase announcement made by the company in May 2024. Medtronic is a constituent of the S&P 500 Dividend Aristocrats index, having increased its annual dividend payment for the past 47 consecutive years. The dividend is payable on January 10, 2025 to shareholders of record at the close of business on December 27, 2024 .

About Medtronic
Bold thinking. Bolder actions. We are Medtronic . Medtronic plc , headquartered in Galway , Ireland , is the leading global healthcare technology company that boldly attacks the most challenging health problems facing humanity by searching out and finding solutions. Our Mission — to alleviate pain, restore health, and extend life — unites a global team of 95,000+ passionate people across more than 150 countries. Our technologies and therapies treat 70 health conditions and include cardiac devices, surgical robotics, insulin pumps, surgical tools, patient monitoring systems, and more. Powered by our diverse knowledge, insatiable curiosity, and desire to help all those who need it, we deliver innovative technologies that transform the lives of two people every second, every hour, every day. Expect more from us as we empower insight-driven care, experiences that put people first, and better outcomes for our world. In everything we do, we are engineering the extraordinary. For more information on Medtronic , visit www.Medtronic.com and follow Medtronic on LinkedIn .

News Provided by PR Newswire via QuoteMedia

Keep reading...Show less
Cardiex Limited (ASX:CDX)

Cardiex Limited


Keep reading...Show less

Bausch Health and Salix in Collaboration with Health Organizations Recognize the Second Annual Opioid-Induced Constipation Awareness Day

Bausch Health Companies Inc. (NYSE:BHC)(TSX:BHC) and its gastroenterology (GI) business, Salix Pharmaceuticals ("Salix"), alongside the U.S. Pain Foundation (USPF), the International Foundation for Gastrointestinal Disorders (IFFGD), and the American Chronic Pain Association (ACPA) have united to recognize today, Thursday, December 5, as the second annual Opioid-Induced Constipation (OIC) Awareness Day. This important day is dedicated to bringing awareness to a commonly-overlooked side effect of opioids. By raising awareness and fostering open conversations, OIC Awareness Day seeks to reduce the stigma surrounding this condition and offer support to the many patients impacted by OIC

"As an organization dedicated to supporting individuals living with pain conditions, we're proud to participate in this year's OIC Awareness Day," said Kathy Sapp, CEO of ACPA. "By increasing awareness and improving communication between healthcare providers, patients, and caregivers, we can make a meaningful difference for those affected by this commonly occurring condition."

News Provided by ACCESSWIRE via QuoteMedia

Keep reading...Show less

Global Medical Service Robotics Market Project to Exceed $20 Billion in 2024 with Additional Growth Expected

FN Media Group News Commentary - Innovations in robotics technology, including artificial intelligence machine learning, and sensor technology, are enhancing the capabilities of medical robots. These advancements enable more precise surgical procedures, improved rehabilitation processes, and efficient hospital logistics, thus attracting more healthcare facilities to adopt robotic solutions. The market is characterized by a moderate level of merger and acquisition (M&A) activity by the leading players. This is due to several factors, including the desire to expand the business to cater to the growing demand for medical service robots. A report from Grand View Research said that the global medical service robots market size was estimated at USD 20.59 billion in 2024 and is projected to grow at a CAGR of 16.5% from 2025 to 2030. It said: "The growth can be attributed to the introduction of technologically advanced robotic equipment in the healthcare sector and the rise in per capita healthcare spending. Continuous advancements in technology, such as robotic catheter control systems (CCS), data recorders, data analytics, remote navigation, motion sensors, 3D-Imaging, and HD surgical microscopic cameras, are projected to drive industry growth. Furthermore, the introduction of swarm robotics is opening new opportunities for industry. It is a new approach to coordinating multi-robotic systems through swarm intelligence." Active Tech Companies in the markets today include Jeffs' Brands Ltd (NASDAQ: JFBR), Serve Robotics Inc. (NASDAQ: SERV), Symbotic Inc. (NASDAQ: SYM), Microbot Medical Inc. (NASDAQ: MBOT), Medtronic plc (NYSE: MDT).

News Provided by GlobeNewswire via QuoteMedia

Keep reading...Show less

Latest Press Releases

Related News

×