The biggest cardiovascular stories from TCT 2023

Every year, some of the biggest names in cardiovascular technologies come together in one place for TCT.

This year’s 35th edition of the Transcatheter Cardiovascular Therapeutics annual scientific symposium was no different in San Francisco.

Usual suspects like Medtronic and Abbott released data covering a range of products, while other big names like Edwards, GE HealthCare and more had positive updates on their own technologies.

Last year’s TCT event highlighted some significant trends in the cardiovascular space. Let’s see what this year’s symposium brought.

Abbott’s TriClip, MitraClip shine along with drug-eluting stent

Results from Abbott’s TRILUMINATE pivotal trial reinforced the safety and effectiveness of the TriClip system. Abbott also shared data from the MitraClip EXPAND G4 real-world registry at TCT 2023.

TriClip, a transcatheter edge-to-edge repair (TEER) system, treats patients with symptomat…

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Edwards wins CE mark for Mitris Resilia valve

The Mitris Resilia valve. [Image courtesy of Edwards Lifesciences]Edwards Lifesciences (NYSE: EW) + announced today that it received CE mark approval for its Mitris Resilia tissue valve replacement.

News of the latest regulatory milestone follows the receipt of CE mark approval for the Evoque valve system last week. Edwards also reported positive TAVR data at TCT 2023 and recorded third-quarter sales growth in its latest earnings report.

The company designed this valve, made with bovine pericardial tissue technology, specifically for the heart’s mitral position. Bovine tissue technology reduces calcium build-up on the valve, preserving and protecting the tissue. It allows the valve to potentially last longer than conventional bioprosthetic valves.

Mitris Resilia features a saddle-shaped sewing cuff that mimics the asymmetric shape of the native mitral valve. Edwards based its low-profile valve on the Perimoun…

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State of the industry — Execs ‘more bullish than ever’ on medtech

From left: Kevin Lobo, Lisa Earnhardt, Deepak Nath, Bernard Zovighian. All spoke about the state of the industry at The MedTech Conference.

Ernst & Young’s 2023 Pulse of the Industry medical technology report may not have been overly positive, but medtech executives certainly are.

The EY report highlighted sluggish revenues and post-COVID-19 corrections leading to a growth decline. In fact, it was the lowest growth in medtech since 2015. Roughly half of medtech stock price gains realized in 2021 were wiped out by the end of 2022.

However, leading medtech executives, including Stryker CEO Kevin Lobo, only see upwards.

“I feel as bullish as I’ve ever felt in my time in medtech,” Lobo declared.

Lobo, Abbott EVP of Medical Devices Lisa Earnhardt, Smith+Nephew CEO Deepak Nath and Edwards CEO Bernard Zovighian all have positive outlooks for the space. They outlined their views on a panel based around the EY report Monday at T…

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Report: Edwards is cooperating with EU amid antitrust scrutiny

According to reports, Edwards Lifesciences (NYSE: EW) + is the company under scrutiny in Europe for potential antitrust activity.

Reuters reports that the company is working with EU antitrust regulators on the matter. The European Commission said last week that it conducted a surprise inspection at an undisclosed medtech company. It listed that company as active in the cardiovascular space, an area in which Edwards operates. Edwards is one of the market leaders in replacement heart valves, including transcatheter aortic valve replacement (TAVR) technology.

The report says Edwards confirmed itself to Reuters as the company inspected by the European officials. Edwards’ statement to the outlet said it is cooperating with the European Commission and remains confident in its business practices. The company also reportedly told Reuters that it remains committed to healthy, fair competition.

According to a news r…

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Edwards software may reduce duration, severity of hypotension, study says

Edwards Lifesciences (NYSE: EW) + today announced study results that support the use of its Acumen HPI software.

Results from the EU-HYPROTECT registry indicate that using Acumen HPI may help reduce the duration and severity of intraoperative hypotension in patients having non-cardiac surgery. In June, Edwards shared results from the registry that also demonstrated the software’s success.

The company developed Acumen HPI to provide clinicians with information regarding the likelihood of a patient developing hypotension. The software uses an algorithm that calculates data from hemodynamic monitoring in perioperative management. It then leverages predictive analytics to alert clinicians of potential blood pressure drops before they occur.

Acumen HPI received FDA 510(k) clearance in June 2022.

The European, multicenter, prospective, observational registry included 702 patients in its final analysis. Th…

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TAVR sales were up 9% for Edwards in Street-beating Q2

The Sapien 3 transcatheter heart valve (Image from Edwards Lifesciences)

Edwards Lifesciences (NYSE: EW) + shares fell after hours today despite second-quarter results that beat the consensus forecast.

Shares of EW dipped 6.3% to $85.85 apiece after the market closed today. MassDevice’s MedTech 100 Index — which includes stocks of the world’s largest medical device companies — closed the day up 0.6%.

The Irvine, California-based company posted profits of $307.1 million. That equals 50¢ per share on sales of $1.53 billion for the three months ended June 30, 2023.

Edwards recorded a 24.4% bottom-line slide on sales growth of 11.4%.

Adjusted to exclude one-time items, earnings per share came in at 66¢. That snuck in 1¢ ahead of expectations on Wall Street, where analysts projected sales of $1.5 billion.

“We are pleased to report strong second quarter double-digit sales growth while a…

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Study says Edwards software could help reduce hypotension

Edwards Lifesciences (NYSE:EW) today announced results from a registry demonstrating the effect of software on reducing hypotension.

The EU-HYPROTECT registry evaluated patients having non-cardiac surgery. Results indicated that the Edwards Acumen HPI software may help reduce the duration and severity of intraoperative hypotension.

Edwards said the European multicenter prospective observational registry included, in its final analysis, 702 patients. These patients, scheduled for elective major non-cardiac surgery, spanned 12 medical centers in France, Germany, Italy, Spain and the UK. The company said it marks the first multicenter registry involving a predictive monitoring technology. It establishes a large, prospectively college database on hypotension management in patients undergoing non-cardiac surgery. All patients had intraarterial blood pressure monitoring with an arterial catheter and intraoperative Acumen HPI software.

Edwards developed its Acu…

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Hologic CEO MacMillan to chair Illumina’s board

Hologic CEO Stephen MacMillan

Illumina (NASDAQ: ILMN) announced today that its board has elected Hologic CEO Stephan MacMillan to fill a new seat and become its non-executive chair.

Edwards Lifesciences CFO Scott Ullem will fill a second new seat — bringing the number of board seats to 11 at the San Diego–based DNA sequencing and array-based tech developer.

The move comes a week after activist investor Carl Icahn’s nominee — Andrew Teno — knocked out previous board chair John Thompson in a shareholder vote. CEO Francis deSouza survived another challenge from an Icahn-backed nominee.

“Both Steve and Scott collectively bring more than 30 years of experience in healthcare, and the appointments are part of our continual process to attract strong independent directors. We believe these two extremely talented business executives will help broaden the skills of the current Board, especially in the fields of corporate finance and international expans…

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Study backs Edwards aortic valve with Resilia tissue

Edwards Lifesciences (NYSE:EW) today announced new data from a clinical trial evaluating bioprosthetic aortic valves with its Resilia tissue.

Data from the COMMENCE aortic trial demonstrated low rates of structural valve deterioration (SVD) in the bioprosthetic valves. It represents the longest clinical follow-up for Edwards’ valve with Resliia tissue at a mean of 7.7 years. The company presented data today at the 103rd annual meeting of the American Association for Thoracic Surgery.

Resilia, a bovine pericardial tissue treated with anti-calcification technology, serves as the platform for Edwards’ new class of valves. Edwards launched the Sapien 3 valve with Reslia in September 2022. The company is using it while developing the next-generation Sapien X4 valve, which is currently undergoing clinical trials.

The build-up of calcium may cause SVD, potentially impacting the long-term durability of bioprosthetic valves. Edwards says. It designed heart …

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Edwards beats The Street in Q1, raises 2023 guidance to up to 12% sales growth

Edwards Lifesciences  (NYSE: EW) + shares dipped despite first-quarter results that topped the consensus forecast.

Shares of EW were down slightly to $86.72 apiece by the close of trading today. MassDevice’s MedTech 100 Index — which includes stocks of the world’s largest medical device companies — finished the day up slightly.

The Irvine, California–based medical device maker yesterday evening posted profits of $340.5 million. That amounts to 56¢ per share on sales of $1.46 billion for the three months ended March 31, 2023.

Edwards posted an 8.9% bottom-line slide on sales growth of 8.8%. The company attributed the reduction in profits to a less favorable impact from foreign exchange. TAVR sales grew 8% to $948 million, while Edwards’ structural heart revenues grew by 12%. Critical care sales ticked up 5%.

The company noted that overall valve surgery growth came in higher than expected.<…

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The biggest cardiology tech stories from ACC.23

Medtronic, Abbott, iRhythm and more presented new data at a major cardiology conference, ACC.23. [Images courtesy of Medtronic, Abbott and iRhythm] Major medtech players presented a range of intriguing studies at a gathering of some of the biggest names in the cardiology tech space.

Some of the hottest topics were covered this past week at the American College of Cardiology’s Annual Scientific Session Together With the World Congress of Cardiology (ACC.23/WCC) in New Orleans.

Ablation, cardiac implants, monitors and imaging technology represented a handful of the technologies on display. Medtronic, Abbott, Boston Scientific, Edwards and more offered new data on their innovative technologies in these areas.

Here are some of the biggest stories that came out of the cardiology conference.

Excitement builds around using pulsed-field ablation to treat AFib

Medtronic, Boston Scientific and Johnson & Johnson MedTech’s Biosense Webster all released new…

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Edwards Lifesciences finds low re-intervention rates at 10 years for TAVR patients

Edwards Lifesciences (NYSE:EW) today announced data supporting transcatheter aortic valve replacement (TAVR) at 10 years.

An analysis of Medicare data showed a low rate of re-intervention after TAVR out to 10 years. Dr. Suzanne Baron, a Boston-based interventional and structural cardiologist, led the analysis. Edwards presented results at the American College of Cardiology ACC.23/WCC.

Of 230,644 patients treated with transfemoral and transapical TAVR between 2011 and 2021, only 1,880 underwent valvular re-intervention. This translated to a 1.63% rate of re-intervention overall when considering the competing risk of death.

Edwards also said it observed the apparent decrease of re-intervention rates with the introduction of next-generation TAVR technologies.

“The observed, sustained low re-intervention rates as well as the decrease in re-interventions with advanced technology are particularly impactful and provide valuable input into the decis…

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