Cardiovascular Business

Cardiovascular Business

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Cardiology operations, devices and technology in care delivery

FDA Clears Next-Gen Device for Left-Heart Access
NewsApr 14, 2026

FDA Clears Next-Gen Device for Left-Heart Access

Protaryx Medical received FDA clearance for its next‑generation Transseptal Puncture Device, enabling left‑heart access in minimally invasive cardiac procedures. The system features zero‑exchange delivery, an atraumatic design, an echogenic extendable probe and a standardized RF guidewire compatible with multiple electrosurgical...

By Cardiovascular Business
More Patients, Fewer Doctors: Demand Keeps Climbing as the Cardiologist Shortage Continues
NewsApr 13, 2026

More Patients, Fewer Doctors: Demand Keeps Climbing as the Cardiologist Shortage Continues

The United States is confronting a widening cardiologist shortage as an aging population and rising risk factors such as hypertension and obesity drive demand. A Medicus report finds the average hiring cycle for a cardiologist now stretches to 248 days,...

By Cardiovascular Business
FDA Shares Warning About Cath Lab Procedure Kits Due to Risk of Patient Injury
NewsApr 13, 2026

FDA Shares Warning About Cath Lab Procedure Kits Due to Risk of Patient Injury

The FDA issued an early‑alert warning that Medline NAMIC angiographic control syringes, previously recalled in a Class I action, are present in AVID Medical’s cath‑lab convenience kits. Four serious patient injuries have been linked to a loose or fully disconnected syringe...

By Cardiovascular Business
New Data Highlight an Unexpected Link Between Hypercortisolism and Resistant Hypertension
NewsApr 13, 2026

New Data Highlight an Unexpected Link Between Hypercortisolism and Resistant Hypertension

A new observational study reveals that hypercortisolism is present in roughly one‑quarter of patients with treatment‑resistant hypertension, with adrenal nodules identified in about 25% of those cases. The same cohort showed hyperaldosteronism in roughly 20% and a dual hormonal abnormality...

By Cardiovascular Business
PVL After TTVR Linked to Much Lower Survival Rate, Fewer Clinical Benefits
NewsApr 10, 2026

PVL After TTVR Linked to Much Lower Survival Rate, Fewer Clinical Benefits

A new analysis of the TRIPLACE registry shows that paravalvular leak (PVL) after transcatheter tricuspid valve replacement (TTVR) dramatically worsens outcomes. Moderate or greater PVL was present in 6.1% of nearly 400 patients and drove one‑year all‑cause mortality to 39.7%,...

By Cardiovascular Business
SVS Quality Initiative Gathers Data to Improve Vascular Care
NewsApr 10, 2026

SVS Quality Initiative Gathers Data to Improve Vascular Care

The Society of Vascular Surgery’s Vascular Quality Initiative (VQI), launched in 2023, now includes more than 7,000 physicians from vascular, cardiothoracic and neurosurgery specialties. Over 900 hospitals and clinics across North America and Singapore have entered data on roughly 1.4 million...

By Cardiovascular Business
Post-TAVR Bleeding in AFib Patients Much Less Common with Apixaban than Rivaroxaban
NewsApr 9, 2026

Post-TAVR Bleeding in AFib Patients Much Less Common with Apixaban than Rivaroxaban

A new retrospective analysis of more than 4,000 transcatheter aortic valve replacement (TAVR) patients with atrial fibrillation found that apixaban significantly lowers the risk of major bleeding compared with rivaroxaban. Propensity‑score matching created two balanced cohorts of 2,157 patients each,...

By Cardiovascular Business
Medline Recalls Millions of Devices Due to Safety Risk—FDA Threatens ‘Regulatory Action’ in Warning Letter
NewsApr 9, 2026

Medline Recalls Millions of Devices Due to Safety Risk—FDA Threatens ‘Regulatory Action’ in Warning Letter

Medline, an Illinois‑based medical supplier that went public in December 2025, is recalling more than 4 million NAMIC angiographic control syringes and over 1 million procedure kits because of a loose‑connection defect that can cause air embolism or clinician exposure. The FDA...

By Cardiovascular Business
Mount Sinai Announces New Global Center Focused on Heart Valve Disease
NewsApr 8, 2026

Mount Sinai Announces New Global Center Focused on Heart Valve Disease

Mount Sinai Health System launched the Adams Valve Institute, a global center dedicated to advancing care, research and education for heart‑valve disease. Leveraging its No. 2 U.S. cardiology ranking and a record‑breaking surgical program, the institute will create specialized centers of excellence...

By Cardiovascular Business
First Patients Treated in New PFA Trial
NewsApr 8, 2026

First Patients Treated in New PFA Trial

Pulse Biosciences has begun treating the first U.S. patients in the NANOPULSE‑AF pivotal trial using its nPulse nanosecond pulsed field ablation system for drug‑resistant paroxysmal atrial fibrillation. The device delivers five‑second, non‑thermal lesions without catheter repositioning, achieving a median 21‑minute...

By Cardiovascular Business
New Gene Therapy May Help Protect the Hearts of Patients with Friedreich's Ataxia
NewsApr 8, 2026

New Gene Therapy May Help Protect the Hearts of Patients with Friedreich's Ataxia

Lexeo Therapeutics reported early-phase results for its investigational gene therapy AAVrh.10hFXN (LX2006) in Friedreich’s ataxia–associated cardiomyopathy. In a phase 1 trial of 17 adults, a single intravenous infusion was well tolerated and produced signals of cardiac improvement, while neurological scores remained...

By Cardiovascular Business
Long-Term Cardiac Amyloidosis Survival Benefits Seen in Extension Acoramidis Trial
NewsApr 7, 2026

Long-Term Cardiac Amyloidosis Survival Benefits Seen in Extension Acoramidis Trial

The open‑label extension of the ATTRibute‑CM trial demonstrated that the transthyretin stabilizer acoramidis (Attruby) delivers sustained survival benefits out to 54 months in patients with cardiac amyloidosis. Participants who began acoramidis early and remained on therapy showed markedly lower all‑cause...

By Cardiovascular Business
FDA Clears Way for IDE Pivotal Trial of the Topaz Tricuspid Valve Replacement System
NewsApr 7, 2026

FDA Clears Way for IDE Pivotal Trial of the Topaz Tricuspid Valve Replacement System

The U.S. Food and Drug Administration has granted an investigational device exemption (IDE) for TRiCares' Topaz transcatheter tricuspid valve replacement system, allowing a pivotal randomized trial across the United States, Canada, and Europe. The study will involve up to 75...

By Cardiovascular Business
Screening and Treatment for Chronic Kidney Disease in Heart Disease Patients Needs to Be Expanded
NewsApr 6, 2026

Screening and Treatment for Chronic Kidney Disease in Heart Disease Patients Needs to Be Expanded

A new multinational INTERASPIRE study of 4,548 coronary artery disease (CAD) patients found chronic kidney disease (CKD) is under‑detected and undertreated. Relying solely on eGFR missed about half of CKD cases, while adding urinary albumin/creatinine ratio (UACR) captured the majority....

By Cardiovascular Business
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