tavr Archives - Page 2 of 3 - Medical Design Sourcing

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…

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)…

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…

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…

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…

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…

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…

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…

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…

Sapien 3 TAVR offers improved outcomes, reduced cost, Edwards Lifesciences says

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

Edwards Lifesciences (NYSE:EW) today touted a cost-effectiveness analysis that supports transcatheter aortic valve replacement (TAVR) with the Sapien 3.

Irvine, California -based Edwards presented data from the Partner 3 trial during the late-breaking clinical trials at the 33rd Transcatheter Cardiovascular Therapeutics (TCT), the annual scientific symposium of the Cardiovascular Research Foundation.

According to a news release, the analysis comparing TAVR to surgery demonstrated that TAVR with Sapien 3 represents an economically dominant treatment strategy with improved outcomes and reduced cost. The analysis compared healthcare costs, life expectancy and quality-adjusted life for patients with severe aortic stenosis at low risk for surgery, who were treated with TAVR or surgery in the PARTNER 3 trial.

Partner 3 randomized 1,000 patients across 71 centers between March 2…

Medtronic touts 5-year study of self-expadning TAVR platform

Medtronic’s CoreValve Evolut TAVR [Image from Medtronic]Medtronic (NYSE:MDT) today presented five-year clinical data for its CoreValve and Evolut transcatheter aortic valve implantation (TAVI) platforms.

Fridley, Minn.-based Medtronic presented results from the Surgical Replacement and Transcatheter Aortic Valve Implantation (SURTAVI) trial at the 33rd Transcatheter Cardiovascular Therapeutics (TCT) conference.

According to a news release, data from the trial demonstrated that the hemodynamic (blood flow) benefits of the CoreValve and Evolut systems were maintained at five years with an excellent safety profile and stable valve performance in patients with symptomatic, severe aortic stenosis who are at intermediate risk for open-heart surgery.

Rates of all-cause mortality were similar between transcatheter aortic valve replacement (TAVR) with the CoreValve/Evolut platform and surgical aortic valve replacement (SAVR). The TAVR arm demonstrated durable …

Edwards Lifesciences stock slides on Q3 financial results

Edwards Lifesciences (NYSE: EW) reported third-quarter financial results today that exceeded Wall Street’s expectations on profits but narrowly missed on sales.

The Irvine, California–based cardio device company reported earnings of $340.1 million (or 54¢ per share) off sales of $1.31 billion. That’s a 4.6% increase from Q3 2020’s earnings of $325.2 million (52¢ per share) off sales of $1.14 billion.

Edwards reported TAVR sales of $858 million, which were up 15% from the same three months a year ago. Edwards said transcatheter aortic valve replacement (TAVR) sales would have been higher if not for continued pressure on hospitals from COVID-19. The company said TAVR sales outside of the U.S. grew approximately 20% on a year-over-year basis.

Get the full story at our sister site, MassDevice.