Inari Medical reports positive outcomes from FlowTriever study

The Inari Medical FlowTriever device. [Image from Inari Medical]Inari Medical (Nasdaq:NARI) announced today that the FLASH registry evaluating its FlowTriever produced positive results.

The company designed its FlowTriever for device retrieval and aspiration system designed to treat pulmonary embolism (PE). FlowTriever non-surgically removes clot from peripheral blood vessels. Its uses include treatment for PE and clot in transit in the right atrium. It received FDA 510(k) clearance in 2018.

Dr. Catalin Toma of the University of Pittsburgh Medical Center (UPMC) presented data at the 2022 TCT (Transcatheter Cardiovascular Therapeutics) conference. Results from the 800-patient FLASH registry were simultaneously published in EuroIntervention.

Study outcomes

The registry is evaluating real-world patient outcomes after treatment of PE with FlowTriever. It has a primary endpoint of major adverse events comprising device-related mortality or major ble…

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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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Abiomed Impella heart pump performs well in Japan study

Abiomed (Nasdaq:ABMD) announced today that a three-year study in Japan demonstrated positive results for its Impella heart pump.

Danvers, Massachusetts-based Abiomed’s study is an update to 2020 interim analysis. Results were presented at TCT 2022 in Boston.

The investigator-led study evaluated all Impella-supported patients across 109 hospitals in Japan. Of the 1,344 AMI cardiogenic shock (AMICS) patients, 30-day survival rates totaled 81%.

The analysis examined 293 consecutive Impella-supported AMICS patients in the J-PVAD Registry. Results also showed 81% survival at 30 days. Historical cardiogenic shock survival rates without Impella are approximately 50%, Abiomed said in a news release.

“The results of this study demonstrate that when Impella is used and best practices are followed, it is possible to achieve heart recovery and greater than 80% survival rates for patients with AMI cardiogenic shock,” said lead investigator Dr. Junya Ako,…

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ReCor Medical ultrasound renal denervation trial meets primary efficacy endpoint

This ReCor Medical illustration shows the Paradise renal denervation catheter during the procedure. The red circle indicates ultrasound-generated energy producing heat for denervation, while the blue circles illustrate cooling from circulating water within the artery to protect the artery from heat.

ReCor Medical announced that a trial for its Paradise ultrasound renal denervation (uRDN) treatment met its primary efficacy endpoint.

Palo Alto, California-based ReCor’s RADIANCE II pivotal trial evaluated Paradise as a treatment for hypertension. The trial operated under FDA investigational device exemption. Results were presented at TCT 2022 in Boston. They follow the company’s July announcement that Paradise met its primary endpoints in the same trial.

The randomized, sham-controlled pivotal trial evaluated 224 patients with uncontrolled hypertension. Patients, randomized 2:1 for uRDN or sham, had to remain off antihypertensive medications throughout…

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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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Boston Scientific Sentinel cerebral protection system does not meet primary endpoint

[Image from Boston Scientific]Boston Scientific (NYSE:BSX) announced that its PROTECTED TAVR clinical trial evaluating its Sentinel system missed its primary endpoint.

Marlborough, Massachusetts-based Boston Scientific designed the Sentinel cerebral protection system to capture and remove embolic debris stemming from transcatheter aortic valve replacement (TAVR). The goal is to extract the debris before it can reach the brain and potentially cause a stroke. Sentinel provides cerebral embolic protection (CEP) during TAVR.

PROTECTED TAVR evaluated periprocedural stroke reduction and neurologic outcomes in patients with aortic stenosis treated with either Sentinel during TAVR or TAVR alone. It did not meet its primary endpoint. Data demonstrated a non-significant trend toward a lower rate of stroke in patients treated with the Sentinel device. The study demonstrated a 21% relative risk reduction in all stroke through 72 hours or time of hospital discharge (2.3% with …

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Data reinforces value of Abbott MitraClip for treating MR

The MitraClip TMVR device [Image courtesy of Abbott]Abbott (NYSE:ABT) today announced post-approval study results supporting its MitraClip G4 system for treating mitral regurgitation (MR).

The company presented data from the EXPAND G4 study at the 34th Transcatheter Cardiovascular Therapeutics (TCT) annual scientific symposium of the Cardiovascular Research Foundation in Boston. EXPAND G4 evaluated MitraClip G4, the company’s transcatheter edge-to-edge repair (TEER) device for treating leaky valves in people with MR.

EXPAND G4 data support the safety and effectiveness of MitraClip G4. Abbott said in a news release that the study represents the largest report of 30-day core lab-assessed outcomes. Data from more than 1,000 patients confirm that MitraClip offers high success rates in terms of MR reduction. It also demonstrated improvements in quality of life and low adverse event rates.

Through 30 days, M…

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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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