Edwards Lifesciences Corp.’s foray into smart recovery technologies already allowed physicians to foresee when critical care patients are at risk of low blood pressure events.
Now, for the first time, the technology is applicable to lower-risk surgical patients who don’t require an invasive arterial line to be monitored in hospital settings.
It’s the latest sign of innovation at Orange County’s most valuable public company (NYSE: EW), whose stock last week hit an all-time high, at one point pushing its market value over $62 billion for the first time.
The Irvine-based device maker is best known for its heart valves and related products, which allow for less-invasive, catheter-based heart repair and replacement procedures.
Edwards also has a growing collection of products—catheters, monitoring systems and other products primarily used for hemodynamic, or blood flow, monitoring—that fall within its emerging critical care division.
That division got a boost this month when it received FDA clearance for its Acumen IQ Finger Cuff, a device which pairs with its software that predicts low hypotension, a condition that can lead to organ damage and death. It’s expected to launch in the U.S. and Europe in the fourth quarter.
The Acumen Hypotension Predictive Index uses machine learning to grade a patient’s likelihood of developing the condition, updating the score every 20 seconds and providing continuous predictive insights.
The Acumen HPI algorithm was trained on more than 59,000 hypotensive and 144,000 non-hypotensive events and has been proven in clinical studies to have a positive predictive value of at least 98%.
The company’s latest predictive technology “demonstrates our commitment to patient care and providing clinicians with ‘smart’ monitoring tools that allow for better prediction and management,” said Katie Szyman, Edwards’ corporate vice president and general manager of critical care.
Edwards has tripled the size of its R&D team in the last five years, and about 40% of those employees are focused on software and artificial intelligence advancements, Szyman told the Business Journal last week.
Shifting ‘Smarter’
Acumen IQ cuff is the newest addition to Edwards’ critical care portfolio, which is comprised of the HemoSphere monitoring system, and various software, sensors and catheters used to aid surgical recovery for over 14 million patients each year.
It has an installed base of about 20,000 monitoring systems in operating rooms and intensive care units globally, and about 25% to 30% of its customers have adopted products from the smart recovery suite.
The 3,000-person unit—including about 10% based in Irvine—is increasingly focused on shifting its product mix to smart recovery, which advances clinician decision-making and is believed to have the highest growth potential within the expanding critical care division of Edwards.
To that end, the company aims to grow smart recovery products from 20% of its portfolio today to about 50% in the next five to seven years, Szyman said.
While other companies such as Irvine device maker Masimo Corp. (Nasdaq: MASI) are looking to introduce their monitoring products in home care settings (see story, page 1), Edwards is focused on growing within hospitals, where about 50% of patients go unmonitored.
“We envision expanding into more operating rooms and general wards for a world where all patients inside hospitals are monitored properly,” Szyman said.
Successful Q1
Critical care is the second-smallest reporting unit at Edwards, generating about $725.4 million or about 16% of overall sales annually. Revenue dipped 2% in 2020 compared to a year ago amid pandemic-related impacts to its hospital customers.
Edwards, companywide, reported some $4.4 billion of sales last year, with 65% of that from its main heart valve division.
A rebound appears underway for the critical care group, which saw sales grow 7% to $196 million in the first quarter ended March 31, the company said, citing higher hospital spending amid waning cases of COVID and related hospitalizations.
“We’re seeing recovery in hospital’s capital replacement cycle, and we anticipate being on guidance in 2021,” Szyman said, referring to projections of between 5% to 10% growth for the unit.
First-quarter results exceeded expectations across all company units, in April pushing Edwards’ stock to an all-time high of $97.45 and past a $60 billion market cap for the first time.
Shares took another jump last week, and approached $100 for the first time.
Real-World Evidence
Clinical trial and follow-up results presented at the EuroPCR conference late last month also demonstrated support for Edwards’ largest and smallest business units: transcatheter aortic valve replacement (TAVR) and transcatheter mitral and tricuspid therapies (TMTT).
â– In a real-world registry analysis of over 6,000 patients treated with the company’s Sapien 3 TAVR at low surgical risk, the all-cause mortality rate for bicuspid valves was low and similar at one year when compared to those with tricuspid valve disease (4.6% versus 6.6%), as were stroke rates at one year (2% versus 2.1%).
The data supports TAVR for patients living with bicuspid aortic stenosis, a type of valve disease affecting valves with only two leaflets rather than three, which is a congenital condition and often requires treatment in younger patients.
â– In a study of 56 patients examined 30 days after a transcatheter tricuspid valve replacement procedure using the company’s Evoque system, 98% of participants experienced mild or non-traceable leakage. The study also showed device and procedural success rates of 98% and 94%, respectively.
