tavr Archives - Medical Design Sourcing

Medtronic has positive Evolut TAVR data

The CoreValve Evolut TAVR implant. [Image courtesy of Medtronic]Medtronic (NYSE: MDT) + today reported two different datasets that support its Evolut transcatheter aortic valve replacement (TAVR) system.

A cost-effectiveness analysis demonstrated the positive economic value of TAVR using Evolut in low-risk patients. It compared Evolut to surgical aortic valve replacement (SAVR). Then, Medtronic had contemporary data from its Evolut low-risk trial reinforcing long-term TAVR outcomes compared to SAVR.

Medtronic presented data at the Cardiovascular Research Technologies (CRT) 2024 Conference. The data follows Medtronic’s TCT presentation highlighting the success of TAVR when pitted against SAVR last October.

“At Medtronic, we continue to emphasize that valve design matters. These data further exemplify Medtronic’s dedication to providing differentiated treatment options like the Evolut …

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…

Boston Scientific completes enrollment in next-gen aortic valve registry

The Acurate Prime aortic valve system XL. [Image courtesy of Boston Scientific]Boston Scientific (NYSE:BSX) announced today that its ACURATE Prime XL Nested Registry completed patient enrollment.

The registry evaluates the Acurate Prime aortic valve system, the Marlborough, Massachusetts-based company’s next-generation technology. It enhances the Acurate neo2 transcatheter aortic valve replacement (TAVR) system, including a full-sized matrix. The system treats patients with severe symptomatic aortic stenosis across all surgical risk levels.

Boston Scientific’s study investigates the safety and effectiveness of the larger Acurate Prime aortic valve XL (29mm). It includes 50 nonrandomized patients across 20 centers in the U.S., according to a LinkedIn post. All subjects previously enrolled in the main randomized controlled trial cohort of the ACURATE IDE trial.

In the non-randomized registry, a cohort of subjects receive Acurate Prime. Boston Scie…

J&J’s Abiomed recalls Impella again — this time it’s TAVR-related

This illustration shows the Impella 5.5 with SmartAssist placed in the heart. [Image courtesy of Abiomed]Johnson & Johnson’s (NYSE: JNJ) + Abiomed unit issued another recall for some of its Impella heart pumps.

FDA communications dated July 14 confirmed the second recall in a month for certain Impella products. In June, the company recalled 466 Impella 5.5 with SmartAssist devices. Abiomed initiated that recall after receiving complaints relating to purge fluid leaking from the purge sidearm of the pump.

The latest medical device correction notice sent by Abiomed includes potential issues with six Impella models. It covers the Impella 2.5, Impella 5.0, Impella 5.5 with Smart Assist, Impella LD, Impella CP and Impella CP with Smart Assist. The issue relates to potential contact with transcatheter aortic valve replacement (TAVR) implants.

This marks the first communication regarding the issue in the U.S., a…

Medtronic touts 3-year data for Evolut TAVR

The CoreValve Evolut TAVR implant. [Image courtesy of Medtronic]Medtronic (NYSE:MDT) announced three-year data supporting its Evolut transcatheter aortic valve replacement (TAVR) system.

Findings from the Evolut Low-Risk trial demonstrated numerically better clinical outcomes for the Evolut TAVR system. It also showed significantly better hemodynamic valve performance compared to surgical aortic valve replacement (SAVR). The study evaluated a low-risk aortic stenosis (AS) patient population.

Medtronic presented data at the American College of Cardiology’s 72nd Annual Scientific Session Together with World Heart Federation’s World Congress of Cardiology. Results were published simultaneously in the Journal of the American College of Cardiology.

In a news release, Dr. John Forrest of the Yale School of Medicine called the need to understand the durability of TAVR “critical.”

“With an increasing number of younger, low-risk patients undergoin…

Data backs durability of Medtronic CoreValve Evolut TAVR

The CoreValve Evolut TAVR implant. [Image courtesy of Medtronic]Medtronic (NYSE:MDT) today announced five-year data that supports its CoreValve Evolut transcatheter aortic valve replacement (TAVR) implant.

Dr. Steven Yakubov presented findings at the 2023 annual meeting of Cardiovascular Research Technologies (CRT 2023). The data showed significantly better valve performance and durability compared to surgical aortic valve replacement (SAVR). Medtronic’s study evaluated bioprosthetic valve dysfunction (BVD) with TAVR at five years.

CoreValve and the next-generation Evolut TAVR systems offer a valve replacement procedure that is less invasive than traditional open-heart surgery for patients with severe aortic stenosis.

Yakubov, who serves as system chief of structural heart disease at the Ohio Health, Riverside Methodist Hospital, said the results add further proof of the benefits of TAVR compared to surgery.

“With valve durability becoming mor…

Abbott wins FDA nod for its Navitor transcatheter aortic valve implant

The Navitor system. [Image from Abbott’s website]Abbott (NYSE:ABT) announced today that it received FDA approval for its latest-generation transcatheter aortic valve implantation (TAVI) system.

The company designed the Navitor system for treating people with severe aortic stenosis at high or extreme risk for open-heart surgery. It adds to Abbott’s transcatheter structural heart portfolio of less invasive treatment options for serious heart diseases.

Abbott entered the U.S. TAVR and TAVI market in 2021 with FDA approval of its Portico with FlexNav system. The company is seeking to compete in a space that Edwards Lifesciences and Medtronic have dominated in the U.S.

Navitor features the NaviSeal unique fabric cuff. This reduces or eliminates the backflow of blood around the valve frame known as paravalvular leak (PVL).

More about Abbott’s Navitor TAVI system

Abbott said in a news release that Navitor is the only self-expanding TAVI sy…

Medtronic reports positive study results for next-gen Evolut FX TAVR system

The Evolut FX TAVR system. [Image courtesy of Medtronic]Medtronic (NYSE:MDT) today presented positive results for its next-generation transcatheter aortic valve replacement (TAVR) system.

The study compared the next-generation Evolut FX TAVR systems to earlier-generation Evolut systems. Data demonstrated significantly improved commissure alignment during TAVR procedures with Evolut FX.

A late-breaking presentation at PCR London Valves 2022 summarized the early limited market release of Evolut FX. The FDA approved the Evolut FX in August 2021. The study included data from 168 patients across six U.S. centers. It compared that data to outcomes for 378 Evolut PRO+ patients from a single center.

Medtronic said in a news release that commissure alignment represents a key aspect of TAVR procedures. It could provide easier future coronary access and improved coronary blood flow. It may also improve valve hemodynamic performance and facilitate redo-TAVR in the futu…

Data backs Boston Scientific Acurate neo2 aortic valve

Acurate Neo2 [Image from Boston Scientific]Boston Scientific (NYSE:BSX) announced positive results from its post-market clinical follow-up study for the Acurate neo2 aortic valve system.

Marlborough, Massachusetts-based Boston Scientific’s findings included a high procedural success rate of 98.4%. The study observed low rates of mortality and paravalvular leak (PVL).

Findings, presented at PCR London Valves 2022, simultaneously published in EuroIntervention, according to a news release.

The European study included a primary safety endpoint of all-cause mortality set at 0.8% at 30 days. Data also demonstrated that no patients experienced greater than moderate PVL. It found that 1.9% experienced moderate PVL and 18.9% experienced mild PVL. Other findings included a low 6.5% rate of new pacemaker implantation at 30 days post-procedure. Boston Scientific’s device demonstrated no incidence of disabling stroke or acute kidney injury.

“Wit…

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 …

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…

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…