The cardiovascular technology (cardiotech) market is vast and difficult to keep up with.

There are so many sectors—cardiac rhythm management, structural heart, electrophysiology, patient monitoring, imaging, surgical devices, stents, and the list goes on. Let’s boil down the latest innovations sweeping the cardiotech market.

MAGiC Tricks

Stereotaxis’ MAGiC Sweep is a robotically-navigated, high density electrophysiology (EP) mapping catheter. When used with the company’s robotic systems, it provides rapid and detailed electroanatomical mapping using data collected simultaneously from 20 electrodes. It maps complex anatomy with the safety of an atraumatic catheter and without the anatomic distension caused by rigid catheters.

The first procedures with MAGiC Sweep were logged at the Deborah Heart and Lung Center in Browns Mills, N.J. The company launched it in the U.S. after securing FDA clearance and it has been submitted for regulatory clearance in Europe.

“Navigating MAGiC Sweep to any desired cardiac location was easy, the catheter maintained stable contact with cardiac tissue, electrogram signals were very clear, and the catheter caused no ectopy in the ventricle,” said Dr. Pedram Kazemian, program director of EP Fellowship at Deborah Heart and Lung Center, who performed one of the first procedures.

Building a Better Heart

SynCardia is the maker of the world’s first U.S. and Canadian commercially-approved total artificial heart (TAH). The company strengthened its intellectual property portfolio with a new patent covering the next-generation SynCardia TAH, the “Emperor.”

The patent relates to the apparatus, systems, and methods to enable a next-generation total artificial heart that provides enhanced flexibility. The Emperor is planned to be fully implantable and offer pulsatile flow without needing an external pneumatic driver.

“The Emperor represents the future of treatment for end-stage heart failure patients,” said SynCardia COO Matt Schuster. “By securing 34 claims across three U.S. patents and extending protection into China, we have created a strong international foundation around our next-generation platform.”

Setting the Pace

Medtronic began a pivotal study to assess its elevated and personalized cardiac pacing rate to treat heart failure with preserved ejection fraction (ELEVATE-HPpEF). The study will investigate a potential novel HFpEF treatment by using conduction system pacing to improve outcomes and heart failure systems. The company hopes to use the results to chase a new pacing indication for HFpEF patients, who have limited clinically proven treatments.

Conduction system pacing taps into the heart’s natural electrical pathways to stimulate a coordinated heartbeat, mimicking the heart’s physiologic contractions. Physicians will program study patients’ pacemakers to either a personalized cardiac pacing rate using an allometric scale based on body size, and baseline left ventricular ejection fraction.

“With the initiation of this study, we are opening the door to our next era—pacing therapy as a potentially safe and effective intervention to improve the lives of patients with HFpEF, a cardiac condition that pacemakers do not currently treat,” said Robert C. Kowal, M.D., Ph.D., general manager for Cardiac Pacing Technologies in Medtronic’s Cardiovascular business.

Striking a Nerve

Pulnovo Medical earned two investigational device exemption (IDE) approvals from the FDA for its PADN (Pulmonary Artery Denervation) catheter. The first is an HDE study approved for patients with Group I PH (pulmonary hypertension), and the second is a PMA study approved for Group II (PH due to left heart disease) patients, with CMS full coverage approval. This paves the way for upcoming clinical trials in the U.S.

The company said both trials are important to evaluate PADN in diverse populations with PH and HF. PADN products have over 1,000 clinical applications across countries like Portugal, Georgia, Singapore, Malaysia, and China. The results of these studies aim to generate valuable data to further evaluate PADN.

Taking the Heat Off 

Pulse Biosciences was granted FDA IDE approval for a study of its nsPFA (nanosecond pulsed field ablation) Cardiac Surgery System, NANOCLAMP AF, to treat atrial fibrillation (AFib). 

The nsPFA Cardiac Clamp delivers continuous, linear, transmural ablations during concomitant cardiac surgeries. The bipolar device uses nonthermal nsPFA tech, which may provide safety and performance advantages over thermal ablation methods.

The study aims to demonstrate the nsPFA Cardiac Surgery System’s primary effectiveness in AFib treatment in concomitant surgical procedures.

“The study approval is a testament to the quality of the preclinical and human clinical data that has been generated in support of this breakthrough technology,” said Pulse Biosciences Co-Chairman and CEO Paul LaViolette. Pulse Biosciences is the first company to advance PFA into the cardiac surgical field for the treatment of AF.”