4 major cardiology trends you need to know from TCT 2022

Medtronic, Edwards and Abbott presented positive data as TAVR, TEER and renal denervation innovations continue to arrive.

The 34th Transcatheter Cardiovascular Therapeutics (TCT) conference took place in Boston this past week and a ton of big names made waves with their technologies and innovations.

Medtronic, Abbott, Edwards and Boston Scientific represent a few of the companies revealing new data for their cardiovascular offerings. ReCor Medical, Abiomed and more got involved, too.

Plenty of the study outcomes represented positive steps forward, while other companies hit speed bumps in their efforts. Here are some of the biggest takeaways from the conference:

1. Renal denervation innovations plug along

Medtronic (NYSE:MDT) announced study data that demonstrates significant blood pressure reduction with the Symplicity renal denervation system.

The RDN minimally invasive procedure delivers radiofrequency energy to specific nerves near the …

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Medtronic presents positive data on TAVR, TMVR devices

Medtronic Evolut TAVR. [Image from Medtronic]Medtronic (NYSE:MDT) announced data from multiple trials supporting its transcatheter heart valve replacement devices.

Data were presented at the 34th Transcatheter Cardiovascular Therapeutics (TCT) conference in Boston. Results covered the company’s self-expanding transcatheter aortic valve replacement (TAVR) devices and its transapical transcatheter mitral valve replacement (TMVR) system.

Medtronic kicked off TCT by announcing the full U.S. launch of its next-generation Evolut FX TAVR system.

Examining HALT in Medtronic CoreValve and Evolut program

The Pathological Study of Hypo-Attenuated Leaflet Thickening (HALT) represents part of the CoreValve and Evolut program. It compares microCT and histology findings of valve leaflet thickening. Medtronic said in a news release that the trial is the first to compare such things. It may provide clinical insights into the long-term durability of transcatheter aorti…

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Medtronic fully launches its next-gen TAVR in U.S.

The Evolut FX TAVR [Image courtesy of Medtronic]Medtronic (NYSE: MDT) marked the start of the TCT 2022 conference today by announcing the full U.S. launch of its Evolut FX TAVR system.

The medtech giant’s next-generation TAVR won FDA approval in 2021, followed by a limited roll out earlier this year. Edwards Lifesciences —Medtronic’s major U.S. competitor in the transcatheter aortic valve replacement space — announced the launch of its next-gen Sapien 3 Ultra Resilia heart valve earlier in the week.

The Evolut FX system incorporates design changes. For example, it includes gold markers built into the frame to provide implanters with direct visualization of commissure alignment.

There’s also a redesigned catheter tip for a smoother insertion profile. Delivery system flexibility features include an optimized stability layer for a more stable, predictable deployment. As with its Evolut Pro+ predecessor, there are four valve sizes — a large in…

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JenaValve completes enrollment in TAVR trial

JenaValve announced today that it successfully completed patient enrollment in a trial evaluating its Trilogy heart valve system.

Irvine, California-based JenaValve develops and manufactures differentiated transcatheter aortic valve replacement (TAVR) systems. It designed Trilogy for high surgical risk patients with symptomatic, severe aortic regurgitation (AR).

JenaValve’s prospective, single-arm ALIGN-AR trial is operating under FDA investigational device exemption. The company designed the trial to assess the Trilogy heart valve system in high-risk patients with symptomatic, severe aortic regurgitation (ssAR).

Last week, the company closed a $100 million Series C financing round. It said it planned to use proceeds to complete its IDE trial for Trilogy. It plans to use results to support a future premarket approval (PMA) submission to the FDA.

“Completing the ALIGN-AR trial is a significant step forward for the cardiology community in addr…

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Study supports Boston Scientific’s Acurate neo2 aortic valve system

Acurate Neo2 [Image from Boston Scientific]New registry data demonstrates positive hemodynamic performance and clinical outcomes with the Boston Scientific (NYSE:BSX) Acurate neo2.

Dr. Andrea Scotti of the Montefiore Medical Center (New York) presented data on the current-generation aortic valve system at TVT: The Structural Heart Summit. It was simultaneously published in EuroIntervention.

In an investigator-driven study, retrospective registry data from 2,026 patients across 34 European centers compared outcomes with the previous generation Acurate neo valve from the NEOPRO registry (1,263 patients in 18 centers) with outcomes for the Acurate neo2 valve from the NEOPRO2 registry (763 patients in 16 centers).

Results demonstrated a significant reduction in moderate or severe paravalvular aortic regurgitation (PAR) for the Acurate neo2 valve 2% vs. 5% with Acurate neo), meeting the primary endpoint with a higher Valve Academic Research Consortium 3 (VARC-3)…

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Boston Scientific’s Acurate Neo2 valve performs well in studies

Acurate Neo2 [Image from Boston Scientific]Boston Scientific (NYSE:BSX) announced positive outcomes from studies of its Acurate Neo2 aortic valve system.

Initial outcomes from the Neo-Align study of 170 patients who underwent transcatheter aortic valve implantation (TAVI) with Acurate Neo2 using a novel implant technique to attempt commissural alignment of the prosthetic and native valves demonstrated that commissural alignment can be achieved safely, effectively and quickly.

Data showed that 97% of patients had no significant misalignment (80% none, 17% mild, 1.2% moderate and 1.8% severe) and the average alignment time of 92 seconds had a minimal impact on procedure duration, according to Boston Scientific. Post-procedure and 30-day safety events were consistent with expected TAVI complication rates, while small manipulations of the delivery system in the ascending aorta did not adversely impact safety outcomes.

The company also reported new findings from…

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Medtronic enrolls first patient in trial of Evolut TAVR system in patients with aortic stenosis

Medtronic (NYSE:MDT) announced today that it enrolled the first patient in its Expand TAVR II pivotal trial.

Expand TAVR II will evaluate the self-expanding, supra-annular Evolut transcatheter aortic valve replacement (TAVR) platform in patients with moderate, symptomatic aortic stenosis (AS), a population outside of current guidelines and indications for TAVR.

According to a news release, the first patient was enrolled by a team led by Dr. Shigeru Saito and Dr. Tomoki Ochiai at Shonan Kamakura General Hospital in Kamakura, Japan.

The multi-center, international, prospective trial will be conducted in the U.S., Canada, Japan, EMEA regions, Australia and New Zealand, following FDA investigational device exemption approval in October 2021 and clinical trial approval from the Japan Pharmaceutical and Medical Device Agency (PMDA) in February 2022.

Medtronic said the trial will evaluate the safety and effectiveness of the Evolut Pro+ TAVR system and gu…

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FDA approves two clinical trials for HLT’s TAVR system

[Image from HLT’s website]HLT announced today that it received FDA approval for two clinical studies for its HLT Meridian transcatheter aortic valve replacement (TAVR) system.

Maple Grove, Minnesota-based HLT, a Bracco Group Company, will conduct the studies to assess the performance of the HLT Meridian TAVR system in treating aortic stenosis and aortic regurgitation among high-risk patients suffering from aortic disease.

The company designed the HLT Meridian TAVR system to offer the benefits of both balloon-expandable and self-expanding platforms with a lower profile and non-obstructive design that reduces coronary and conduction obstruction, according to a news release.

HLT said the design aims to increase hemodynamic performance to reduce the concern of patient-prosthesis mismatch. The company added that the HLT Meridian TAVR system represents the only TAVR valve with an isolated valve structure where leaflets are not attached to an annular structu…

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Edwards Lifesciences misses on Q4 earnings as omicron hammers hospitals

Edwards Lifesciences (NYSE:EW) posted fourth-quarter earnings at the end of trading today that fell short of the consensus forecast on Wall Street, but reaffirmed its outlook for 2022.

The Irvine, California-based heart device company reported profits of $335.3 million — or $0.53 per diluted share — on sales of $1.33 billion for the three months ended Dec. 31, 2021, for a bottom-line gain of 8% and sales growth of 12% compared with Q4 2020.

Transcatheter aortic valve replacement (TAVR) sales grew to $872 million for the quarter, up 12 percent despite the “pronounced impact on hospital resources in December” from the omicron variant of COVID-19, said CEO Mike Mussallem, who cited the delta variant wave in the company’s third-quarter results.

TAVR sales outside the U.S. grew about 20 percent on an underlying basis in Q4, and Edwards Lifesciences said it continues to project that the global TAVR opportunity will double to $10 billion by 20…

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Abbott sees the delivery system as a differentiator for its TAVR

A top Abbott executive explains how the company’s FlexNav delivery system could make the Portico TAVR competitive. The Portico with FlexNav TAVR system [Image courtesy of Abbott]Abbott is aiming to claw away market share from transcatheter aortic valve replacement pioneers  Edwards Lifesciences and Medtronic.

The Abbott Park, Illinois–based medtech company in September announced FDA approval of its Portico with FlexNav TAVR system, more than a year after it secured CE Mark approval in Europe. For now, the approval covers symptomatic, severe aortic stenosis associated with a high or extreme risk for open-heart surgery.

The Portico valve boasts a self-expanding design with intra-annular (within the native valve) leaflets. The Portico’s creators designed its structure to provide optimal blood flow when placed inside a patient’s natural valve. It also preserves access to the critical coronary arteries for future interventions.

But Santosh Prab…

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Abbott sees the delivery system as a differentiator for its TAVR

A top Abbott executive explains how the company’s FlexNav delivery system could make the Portico TAVR competitive.

The Portico with FlexNav TAVR system [Image courtesy of Abbott]

Abbott is aiming to claw away market share from transcatheter aortic valve replacement pioneers  Edwards Lifesciences and Medtronic.

The Abbott Park, Illinois–based medtech company in September announced FDA approval of its Portico with FlexNav TAVR system, more than a year after it secured CE Mark approval in Europe. For now, the approval covers symptomatic, severe aortic stenosis associated with a high or extreme risk for open-heart surgery.

The Portico valve boasts a self-expanding design with intra-annular (within the native valve) leaflets. The Portico’s creators designed its structure to provide optimal blood flow when placed inside a patient’s natural valve. It also preserves access to the critical coron…

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FDA approves Edwards Lifesciences Sapien 3 with Alterra for pulmonary regurgitation

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

Edwards Lifesciences (NYSE:EW) announced today that it received FDA approval for the use of its Sapien 3 transcatheter valve with the Alterra adaptive prestent.

Irvine, California-based Edwards garnered the FDA nod for use of the Sapien 3 with Alterra for patients with severe pulmonary regurgitation.

The Sapien 3 transcatheter pulmonary valve (TPV) system combines the Sapien 3 valve and the Alterra adaptive present to expand transcatheter therapy options for congenital heart valve disease patients, Edwards said in a news release. The company designed Alterra to compensate for variations in size and morphology of the right ventricular outflow tract to provide a stable landing zone for the Sapien 3 valve.

Indication for the Edwards Sapien 3 TPV system with Alterra covers the management of pediatric and adult patients with severe pulmonary regurgitation as measured by echoca…

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