Functional Mitral Regurgitation

None Welcome to this week's Chutes & Ladders, our roundup of hirings, firings and retirings throughout the industry. Please submit the good news—or the bad—from your shop, and we will feature it here at the end of each week. Northwell Health Northwell Health, a healthcare provider in New York, has appointed Kristin Myers as its first chief digital officer. She will also serve as executive vice president. Myers will be responsible for “using technology to change the way the patient experience is designed, and also to streamline systems that team members use every day,” according to a press release. She previously spent 20 years with Mount Sinai Health system, most recently as a chief digital and information officer since June 2020. Eleanor Health William McKinney has been named CEO and board member for Eleanor Health, an addiction and mental health provider delivering care through value-based payment models. He previously served as CEO of Sevita, formerly known as The MENTOR Network, a provider of home and community-based specialty healthcare. Before then he was president of the integrated care group for Fresenius Medical Care, held leadership roles for MedSpring Urgent Care and Wellcare Health Plans and consulted for McKinsey. Eleanor Health is in seven markets with 17 value-based contracts, according to a press release. ACGME The Accreditation Council of Graduate Medical Education, a nonprofit organization that accredits 871 institutions and more than 12,000 residency and fellowship programs, will be looking for its next president and CEO. Thomas Nasca, M.D., is stepping down from the position, effective Jan. 1, 2025, to create the ACGME Center for Professionalism and the Future of Medicine, where he will serve as senior fellow and administrative director. Nasca is credited with helping grow the organization, implementing an analytics accreditation system and instituting a Clinical Learning Environment Review program, according to a press release. > Definitive Healthcare, a healthcare commercial intelligence company, has announced Robert Musslewhite has stepped down as CEO and board member. He will be replaced by interim CEO Jason Krantz, the founder and executive chairman of the company. > Aspirus Health, a nonprofit health system in Wisconsin, has named Jerry Yang as CFO, succeeding Sid Sczygelski after a 39-year career, according to a LinkedIn post. > FORM, a virtual obesity medicine clinic founded in 2019, has hired Carey Hutchins as vice president of success and Tom Kahl as vice president of sales. > Equality Health, primary care platform using value-based payment models, has selected Christian Leon as a market president in Arizona. > Spineology, a company specializing in minimally invasive spine surgery, as added Amanda Bloom as executive vice president of marketing. > Iron Bow, an IT solutions provider to government, commercial and healthcare markets, has promoted Scott Sanner to CEO. > Ballad Health, an integrated healthcare system in Tennessee, Virginia, North Carolina and Kentucky, has named Mary Breslin-Rodriguez as chief quality officer. > Unity Health, an Arkansas healthcare system, has announced LaDonna Johnston as interim president and CEO. > Allina Health, a health system in Minnesota and Wisconsin, has announced CFO Ric Magnuson will leave the organization in April. > Cardiac Dimensions, a company that develops minimally invasive treatment modalities for patients with heart failure from functional mitral regurgitation, has appointed Satya Shreenivas, M.D., as chief medical officer. > Roxborough Memorial Hospital in Pennsylvania has appointed Darshan Parekh as CEO, succeeding Burton Piper. > Kalderos, a data analytics company and creator of the first drug discount management platform, has hired Kate Flathers as head of product and Tim Brown as chief operating officer. > Manatt, Phelps & Phillips, LLP, an integrated professional services firm, has welcomed Heide Bajnrauh as managing director. > Troy Regional Medical Center in Alabama has announced CFO Mike Myers is retiring, and he will be replaced by Kathy Hill. > Cozen O’Connor, a full-service law firm, has poached Rick Van Buren from the office of Rep. Frank Pallone (D-NJ), where he was senior health policy counsel. > Saint Agnes Medical Center in Fresno, California has appointed Gurvinder Kaur, M.D., as president and market leader. > NorthBay Health, a nonprofit health system in California and a member of the Mayo Clinic Care Network, has hired Paul McGinty as chief experience officer. > The Innovation and Value Initiative, a nonprofit research organization focused on advancing health technology assessment, has announced four members to its board of directors including Scott Brunner, Susan Cantrell, Lisa Bo Feng and Kisten Monkhouse. > Southcoast Health, a community-based health system in Massachusetts and Rhode Island, has selected Dennis LaRock, M.D., as executive vice president and chief physician officer, effective March 1. > FTI Consulting, a global business advisory firm, has appointed Tanner Kaufman as managing director in its merger & acquisition practice. > Bon Secours, a Catholic health system, has tapped Cassie Lewis as chief nursing officer for the Richmond market, effective Feb. 11. > NORC at the University of Chicago, a nonpartisan research organization, has promoted Angela DeBello as its first chief of staff. > Walgreens Boots Alliance has promoted Beth Leonard to senior vice president and chief corporate affairs officer, succeeding the retiring Chuck Greener, reported PRWeek. > Trinity Health Mid-Atlantic has hired Angel McCullough as chief nursing officer of St. Mary Medical Center and Nazareth Hospital in Pennsylvania. > Lifespan, a health system in Rhode Island, has selected Cindy Peterson as executive vice president of ambulatory care. > Intermountain Spanish Fork Hospital in Utah has named Megan Johnson as president. > Carrot Fertility, a global fertility care leader, has appointed Alli Tiscornia as chief customer officer, replacing Chief Operating Officer Brooke Quinn in her former role. > USC Arcadia Hospital has named Colleen Wilcoxen as chief nursing officer, Robert Begg as vice president of human resources and Lisa Johnson as chief quality officer. Johnson will take up the new role Jan. 29. > Manning Regional Healthcare Center, an affiliate of MercyOne in Iowa, has announced Shannon Black as CEO, beginning Feb. 19. > Valer, a prior authorization and referral management solution, has hired Philip Dolan as chief growth officer and Jennifer Golladay as vice president of client success. > The American College of Radiology, a nonprofit based in Reston, Virginia, has announced Dana Smetherman, M.D., as its next CEO, effective July 1. > AHIP, a national association of health insurance plans, has named Samantha Burch as vice president of technology public policy and Shane Hand as vice president of federal affairs. > Nassau University Medical Center in New York has removed Anthony Boutin, M.D., as its president and chief executive during a board meeting in a unanimous vote, reports Newsday. > UChicago Medicine AdventHealth, an AdventHealth-affiliated hospital, has named Kenneth Rose as president and CEO, the same role he had for Texas Health Hospital Mansfield. > Remedy Place, a social wellness club, has hired Hemik Patel as chief operating officer after more than three years as executive vice president for Sollis Health. > Wiggin and Dana LLP, a national law firm, has appointed Debbie Cardinalli as partner for its healthcare practice.

KIRKLAND, Wash.--( BUSINESS WIRE )-- Cardiac Dimensions ®, a leader in the development of innovative and minimally invasive treatment modalities to address patients suffering from heart failure with functional mitral regurgitation (FMR), today announced that renowned interventional cardiologist Satya Shreenivas, MD, MBA has joined the company as Chief Medical Officer. Dr. Shreenivas brings his rich experience in both the clinical and commercial aspects of the structural heart landscape to his new role with Cardiac Dimensions. He led the structural heart program and cardiac catheterization laboratory at the University of Cincinnati and spent several years with The Christ Hospital in Ohio. There, he served as an investigator in many high-profile clinical trials, including several significant structural heart studies. Dr. Shreenivas is a frequent speaker at major scientific meetings and has been widely published in peer-reviewed journals across the structural heart, heart failure, and coronary arenas. He trained at the University of Pennsylvania and received an MBA from the Wharton School. His industry roles have included serving as Chief Medical Officer for HLT Medical, a transcatheter heart valve company, as Chief of Cardiology with Optum/United Health subsidiary SCA Health, and as Medical Director for clinical research organization Medpace. Dr. Shreenivas has been instrumental in advising Cardiac Dimensions on its EMPOWER Trial of the Carillon Mitral Contour System ®. “We are thrilled to welcome Dr. Shreenivas to Cardiac Dimensions and expect his valuable combination of clinical and industry experience, passion for evidence generation, and innovative spirit will benefit the EMPOWER Trial studying our Carillon device as a therapy for heart failure patients with functional mitral regurgitation,” said Cardiac Dimensions CEO Rick Wypych. “Having a structural heart leader like Satya as a member of the Cardiac Dimensions team will provide us with unique insights for our clinical research, as well as ongoing commercial efforts.” “I’ve seen the compelling clinical evidence on Carillon therapy from Europe and look forward to helping the team expand the supportive body of evidence for this intriguing technology with the U.S. pivotal EMPOWER Trial,” said Dr. Shreenivas. “I have always been energized by my work with emerging technologies that fill an unmet clinical need and am excited by the opportunity this therapy presents to enhance the lives of heart failure patients in a way that isn’t possible today.” About the Carillon Mitral Contour System Many heart failure patients suffer from functional mitral regurgitation, which when left untreated, exacerbates their heart failure, further weakening the heart, degrading their quality of life, and reducing survival. The Carillon Mitral Contour System is designed to treat both FMR and heart failure in one simple, short, minimally-invasive procedure. It is the only commercially available option for transcatheter mitral valve repair (TMVr) in Europe to consistently show favorable left ventricular remodeling while also acutely reducing FMR in clinical trials. Carillon® therapy is a right-sided approach that does not directly touch the mitral valve, allowing for any heart failure intervention a patient may require in the future. The device is designed to eliminate many of the risk-related requirements of other TMVr options – such as general anesthesia, procedural echo, transseptal puncture and patient medication changes – and has been shown in clinical trials to have substantially fewer procedural events than those reported by other therapies. Carillon therapy is included in heart failure treatment guidelines from the European Society of Cardiology (ESC) and is fully reimbursed in Germany and several other European countries. The Carillon Mitral Contour System has obtained the CE Mark for NYHA Class II and greater patients, as well as Therapeutic Goods Approval (TGA), and is commercially available in Europe and Australia. It is considered an investigational device in the U.S. For more information, please visit www.CardiacDimensions.com . About Cardiac Dimensions Cardiac Dimensions is a leader in the development of innovative, minimally invasive therapy that reimagines how patients with heart failure and FMR can be treated and improved. Cardiac Dimensions has operations in Kirkland, Washington, Sydney, Australia and Frankfurt, Germany. Cardiac Dimensions, Carillon, and Carillon Mitral Contour System are registered trademarks of Cardiac Dimensions.

SAN FRANCISCO, Oct. 26, 2023 /PRNewswire/ -- Edwards Lifesciences Corporation (NYSE: EW) announced one-year results from CLASP IID, the first randomized controlled trial that directly compares two contemporary mitral transcatheter edge-to-edge repair (TEER) therapies, as well as one-year results from the CLASP IID registry. The studies confirm the clinical and quality-of-life benefits of mitral regurgitation (MR) reduction with the PASCAL system in a broad population of patients with degenerative mitral regurgitation (DMR). Results from the CLASP IID randomized trial and registry were presented as a late-breaking clinical trial session at the 35th Transcatheter Cardiovascular Therapeutics (TCT), the annual scientific symposium of the Cardiovascular Research Foundation, and simultaneously published in JACC: Cardiovascular Interventions. Patients enrolled in the CLASP IID pivotal trial had significant symptomatic DMR and were determined to be at prohibitive surgical risk. Patients enrolled in the CLASP IID registry met those same criteria yet were deemed ineligible for randomization. One-year results from the CLASP IID randomized trial showed the PASCAL system achieved: Freedom from major adverse events rate of 84.7 percent at one year, and Significant and sustained MR reduction, with 95.8 percent of patients achieving MR ≤2+ at one year. Increasingly, the MR reduction goal with TEER is to achieve MR ≤1+ because contemporary evidence suggests reduced regurgitation may correlate with improved long-term patient outcomes. At one year, 77.1 percent of PASCAL patients in the trial achieved a MR rate of ≤1+. The PASCAL system also showed sustained outcomes of high survival, low heart failure hospitalization and meaningful quality-of-life improvements. "These data from the CLASP IID randomized trial and registry further advance mitral edge-to-edge repair as an important treatment option for a wide range of very sick patients who suffer with debilitating symptoms," said Firas Zahr, MD, director of Interventional Cardiology and co-director of the Complex Heart Valve Program at Oregon Health & Science University and CLASP IID Study Investigator. "Patients receiving the PASCAL system experienced significant improvements in functional capacity and quality of life that were sustained for one year." The CLASP IID trial is a prospective randomized controlled trial comparing the safety and effectiveness of the PASCAL system to the MitraClip system. Results were reported on 300 patients with 2:1 randomization (204 PASCAL / 96 MitraClip), with clinical events committee and echo core lab adjudication. The CLASP IID registry enrolled 98 patients. The trial and registry included 57 sites in the US, Canada and Europe, with most clinical operators new to using the PASCAL system and all having experience with the MitraClip system. "We are pleased that these one-year results affirm the safety and effectiveness of the PASCAL system and the benefits of TEER for this undertreated patient population," said Daveen Chopra, Edwards' corporate vice president, transcatheter mitral and tricuspid therapies. "Growing our body of clinical evidence in support of our patient-driven therapies is a high priority at Edwards, and we are committed to pursuing multiple pivotal trials in our efforts to transform treatment for a broad population of patients in need." As part of Edwards' continued commitment to building robust real-world evidence, patients receiving the PASCAL Precision system in the US are enrolled in a post-market registry for five years. Additional ongoing studies of the PASCAL system include the single-arm CLASP trial and European post-market MiCLASP registry. The PASCAL Precision system is one of multiple transcatheter repair or replacement therapies in development by Edwards and is approved for degenerative mitral regurgitation in the US and Japan and has CE Mark for the treatment of mitral degenerative and functional regurgitation, and tricuspid regurgitation. About TEER Transcatheter Edge-to-Edge Repair (TEER) of the mitral valve is used in the treatment of MR. TEER approximates the anterior and posterior mitral valve leaflets by grasping them with a clasping device in an approach similar to a treatment developed in cardiac surgery called the Alfieri stitch. 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 Edwards.com and follow us on Facebook, Instagram, LinkedIn, Twitter 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. These forward-looking statements include, but are not limited to, statements made by Mr. Chopra and statements regarding expected product benefits, patient outcomes, 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 results to differ materially from those expressed or implied by the forward-looking statements based on a number of factors as detailed in the company's filings with the Securities and Exchange Commission, including its Annual Report on Form 10-K for the year ended December 31, 2022, and its Quarterly Reports on Form 10-Q for the quarters ended March 31 and June 30, 2023. These filings, along with important safety information about our products, may be found at Edwards.com. Edwards, Edwards Lifesciences, the stylized E logo, CLASP, Edwards PASCAL, Edwards PASCAL Precision, MiCLASP, PASCAL, and PASCAL Precision are trademarks of Edwards Lifesciences Corporation. All other trademarks are the property of their respective owners. View original content to download multimedia: SOURCE Edwards Lifesciences Corporation Company Codes: NYSE:EW