Top, from left: Boston Scientific’s Acurate neo2, Inari Medical’s FlowTriever, Edwards’ Evoque valve.
Bottom, from left: Medtronic Symplicity Spyral, MitrAssist Sikelia. [Images courtesy of the companies.
This year’s event in Washington, D.C., featured company updates on all types of technologies, including heart valves, access and closure devices, drug-eluting implants, intravascular lithotripsy (IVL), renal denervation (RDN) and more.
Some of the biggest names in cardiovascular care had data backing their innovations. Last year’s TCT event highlighted some significant trends in the cardiovascular space. Here’s a look at what this year’s symposium showcasing some of the world’s most intriguing cardiovascular technologies brought.
Boston Scientific trial misses endpoint
In a study comparing the Boston Scientific Acurate neo2 aortic valve system with the commercially available Edwards Sapien or Medtronic Evolut, Acuate neo2 failed to meet its primary endpoint.
Investigators looked at Acurate neo2, Boston Scientific’s second-generation TAVR technology, in the treatment of patients with severe, symptomatic aortic stenosis at low, intermediate, high and extreme risk of open-heart surgery.
Findings included a 16.16% composite rate of all-cause mortality, stroke or rehospitalization at one year in the Acurate neo2 arm. That compared to 9.53% in the control arm. This failed to meet the pre-specified criterion for non-inferiority.
Despite missing the endpoint, Boston Scientific officials came away with optimism for the technology. Dr. Janar Sathananthan, chief medical officer, Interventional Cardiology Therapies, Boston Scientific, said the results could provide clinicians with “a greater understanding of the impact of procedural optimization as the TAVR space continues to rapidly evolve.”
Analysts, however, say the results could cast doubt over the valve’s pathway through the FDA for U.S. commercialization.
Edwards has positive data for Evoque, early TAVR
Edwards Lifesciences presented data from two trials, both supporting the use of its heart valve technology.
First, the company shared outcomes from a trial looking at the best strategy for treating asymptomatic severe aortic stenosis (AS). Results demonstrated that asymptomatic AS patients randomized to Edwards TAVR experienced superior outcomes compared to guideline-recommended clinical surveillance.
Second, Edwards announced data highlighting the superiority of its Evoque system compared to optimal medical therapy (OMT) alone. It found that Evoque demonstrated superiority compared to OMT alone at the one-year primary endpoint.
“Edwards’ commitment to innovation is inspired by the millions of patients around the world suffering with debilitating symptoms and poor quality-of-life as a result of structural heart diseases and in desperate need of effective treatment options,” said Daveen Chopra, Edwards’ corporate VP, transcatheter mitral and tricuspid therapies.
Read about the early TAVR outcomes here.
Read about the Evoque results here.
Inari Medical touts FlowTriever data
Irvine, California-based Inari Medical designed its FlowTriever for device retrieval and aspiration. The system treats pulmonary embolism (PE). FlowTriever non-surgically removes clots from peripheral blood vessels. Its uses include treatment for PE and clots in transit in the right atrium.
The company at TCT shared positive results from the prospective PEERLESS trial, comparing FlowTriever to catheter-directed thrombolytics (CDT).
PEERLESS met its primary composite endpoint, driven by patients experiencing significantly fewer clinical deteriorations or therapy escalations, fewer ICU admissions, and shorter ICU lengths of stay with FlowTriever versus CDT. Patients also registered faster recovery for clinical symptoms and hemodynamics, shorter hospital stays and fewer 30-day readmissions.
Elixir Medical reports positive outcomes with drug-eluting implant
An evaluation of complex patient populations within the INFINITY-SWEDEHEART randomized controlled trial highlighted the success of Elixir Medical’s DynamX system compared to Medtronic’s Resolute Onyx zotarolimus drug-eluting stent (DES).
Elixir Medical’s sirolimus-eluting DynamX bioadaptor features a novel design and mechanism of action designed to return the diseased vessel to a more normal condition.
Elixir won FDA breakthrough device designation for DynamX earlier this year. The system has CE mark but remains investigational in the U.S.
“We are thrilled that the results from INFINITY-SWEDEHEART and BIOADAPTOR-RCT trials validate the bioadaptor’s unique and novel mechanism of action to restore vessel function and manifest for the first time in PCI history the plateauing of adverse event rates six months after the procedure providing a better treatment option for patients with CAD,” said Motasim Sirhan, CEO and founder of Elixir Medical.
VivaSure’s PerQSeal demonstrates safety and effectiveness
VivaSure shared initial results from the PATCH FDA investigational device exemption (IDE) pivotal study evaluating the safety and efficacy of its PerQseal system at TCT.
Galway, Ireland-based Vivasure designed the latest-generation PerQseal Elite for percutaneous vessel closure. It leverages the legacy platform’s safety profile and ease of use while allowing for faster delivery. The new system also improves performance in calcium and the treatment of large-hole venous procedures. That includes transcatheter mitral and aortic valve repair and replacement (TMVR/TAVR).
The company says PerQseal is the first sutureless, fully absorbable synthetic implant for large-bore vessel punctures. Placement occurs from inside the vessel, making deployment simpler and more controlled than conventional closure techniques.
Andrew Glass, CEO, Vivasure Medical, said: “The results from our U.S. pivotal study, as well as the previous PerQseal studies, indicate that the PerQseal System is safe and effective for patients around the globe.”
CardiaWave’s ultrasound tech meets primary endpoint
Cardiawave said its device for the treatment of severe symptomatic calcific aortic stenosis (CAS) met the primary endpoint in a pivotal study.
Data presented at TCT found that the investigational Valvosoft non-invasive ultrasound therapy (NIUT) device improved or stabilized heart failure symptoms for 80.5% of patients. It substantially improved hemodynamics and patient quality of life six months after treatment.
Cardiawave designed Valvosoft to non-invasively restore leaflet mobility in a stenotic aortic valve. It widens the valve opening to relieve patient heart failure symptoms. High-intensity focused ultrasound waves micro-fracture calcification embedded in aortic valve leaflets without damaging tissue.
MitrAssist’s transthoracic heart valve could improve outcomes
MitrAssist designed its Sikelia transthoracic heart valve technology for transcatheter aortic valve implantation (TAVI) procedures. It features a unique polymer leaflet design, allowing for enhanced durability and reduced thrombogenicity and calcification. The design also helps lower production costs.
Sikelia THV is also fully retrievable at 100% frame expansion, allowing for repositioning in case of misplacement. With a self-expanding nitinol wire frame, the polymer valve has a lifespan of 25 years.
Data presented at TCT demonstrated the potential to improve outcomes for patients suffering from severe symptomatic aortic stenosis. Results came from 12 patients across four centers, with a maximum follow-up of 27 months.
Shockwave hits milestone in all-female IVL trial
Shockwave Medical, now part of Johnson & Johnson MedTech, completed enrollment for its Empower CAD all-female study on percutaneous coronary intervention (PCI) in complex calcific coronary disease. J&J said that investigators completed the final enrollment during a live case at TCT.
The Shockwave study aims to confirm the benefits of coronary IVL in women. Women comprise about a quarter of cardiovascular clinical trial participants, limiting gender-specific data essential for treatment advancements. Female patients undergoing PCI face a higher risk of procedural complications, emphasizing the need for targeted studies.
“We are proud of, and grateful to, all of the dedicated investigators who enrolled this study well ahead of all our expectations, showcasing their commitment to the important issue of women’s cardiovascular care,” Shockwave Medical Chief Medical Officer Nick West said. “This study is a critical step toward closing the gender gap in heart disease treatment, and we recognize the urgent need for clinical data that reflect the unique challenges that women with cardiovascular disease face.”
Johnson & Johnson’s Abiomed hits primary endpoint in Impella ECP study
Another unit at J&J, Abiomed, reported positive data at TCT. This data covered the Impella ECP transvalvular axial flow pump with compressible pump architecture.
J&J said the study, which met its primary endpoint, enrolled 256 patients at 18 sites in the U.S. Its MACCE (Major Adverse Cardiac and Cerebrovascular Events) rate at 30 days came in at 6.3%. That landed significantly below the pre-defined performance goal, according to a news release.
The company said Impella ECP demonstrated safety and efficacy for use in high-risk percutaneous coronary interventions (PCI). Operators chose the 8Fr Angio-Seal as the first closure method in 70% of patients, registering a 92% success rate.
Long-term data supports Medtronic’s RDN tech
Medtronic’s Symplicity Spyral RDN system delivers radiofrequency energy to nerves near kidneys in a minimally invasive procedure to treat hypertension. These nerves can become overactive and contribute to high blood pressure.
The medtech giant reported long-term data at TCT that support the RDN system, following its landmark FDA approval nearly a year ago.
Outcomes from the SPYRAL HTN-ON MED showed subjects who underwent the RDN procedure had significantly greater reductions in 24-hour ambulatory systolic blood pressure (ABPM) and office-based systolic blood pressure (OSBP) compared to sham patients at two years.
Dr. David Kandzari, the study’s principal investigator, called the findings “key” in informing the medical community of RDN’s long-term effectiveness.
HeartFlow reports positive results for AI plaque analysis
The ADVANCE-DK study presented at TCT evaluated HeartFlow’s AI-enabled fractional flow reserve computed tomography (FFRCT) and Plaque Analysis in the assessment of the long-term risk of coronary artery disease (CAD) in clinically stable, symptomatic patients.
Outcomes showed that the HeartFlow platform provides clinicians with the insights needed to anticipate and mitigate adverse events. That includes myocardial infarctions in symptomatic patients with stable chest pain.
Data demonstrated the completeness of revascularization predicts clinical outcomes and can be assessed non-invasively using coronary CCTA and FFRCT. Patients with IR, as assessed by FFRCT, had a higher long-term risk of adverse events than those whose assessment showed CR or patients who had a normal FFRCT. Combined plaque quantification and characterization and lesion-specific physiology from FFRCT also proved to be a superior predictor of adverse cardiovascular events.
