Kardium, Inc.

Senseonics Takes Back the Reins Senseonics is taking back commercialization and distribution of its Eversense continuous glucose monitoring products. The news comes roughly five years after the company partnered with Ascensia Diabetes Care to be the exclusive worldwide distributor of its Eversense CGM systems. Medtronic's Dual FDA Nods for MiniMed 780G Medtronic has received dual FDA nods for its MiniMed 780G system, enabling integration with Abbott's Instinct sensor for type 1 diabetes patients and expanding use to adults with insulin-requiring type 2 diabetes. PFA Market Heats Up FDA has approved Kardium’s Globe pulsed field ablation (PFA) catheter to treat atrial fibrillation. The agency also cleared both the Globe Introducer sheath and the system’s mapping software.

Pulse Biosciences has been granted an IDE for the NANOCLAMP AF Study. The Hayward, CA-based company is developing the Nanosecond Pulsed Field Ablation (nsPFA) to treat Atrial Fibrillation. NANOCLAMP is a single-arm prospective study designed to demonstrate the primary effectiveness of the nsPFA Cardiac Surgical System for the treatment of Afib in concomitant surgical procedures. Up to 20 sites, including two outside of the US, are planned to enroll up to 136 patients. The nsPFA Cardiac Clamp is designed to deliver continuous, linear, transmural ablations during concomitant cardiac surgeries. The bipolar device uses the company’s nonthermal nsPFA technology, which early clinical data suggest may offer safety and performance advantages over traditional thermal ablation methods. Unlike thermal approaches, nsPFA energy minimizes the risk of collateral tissue damage due to its nonthermal mechanism of action. The nsPFA Cardiac Surgical System received Breakthrough Device Designation in July 2024 and is enrolled in FDA’s Total Product Life Cycle Advisory Program. Pulse Bioscience’s first-in-human feasibility study has been underway in the EU since August 2024, with more than 40 patients treated across three sites in the Netherlands. Surgeons have reported rapid ablation times—as short as 2.5 seconds—along with consistent, contiguous, and fully transmural lesions. Pulse Bioscience expects to add additional sites to this study throughout 2025. "We believe nsPFA’s novel and proprietary nonthermal mechanism of cardiac ablation offers significant safety, effectiveness, and speed improvements over current thermal modalities, such as radiofrequency ablation,” said Dr. Niv Ad, Chief Science Officer, Cardiac Surgery at Pulse Biosciences. The first-in-human feasibility data we are generating in Europe gives us confidence in our ability to successfully execute the IDE study, and we look forward to enrolling our first patients.” Pulse Biosciences has a number of competitors in the PFA space. Last week, Kardium won FDA approval for the Globe PFA catheter. In July , the Vancouver, Canada-based company raised $285 million in a financing round.

In a U.S. clinical trial presented earlier this year, Kardium\'s catheter took an average of about 25 minutes to isolate all four of the heart’s pulmonary veins, with about five total minutes of X-ray fluoroscopy. \n Kardium has collected an FDA approval for its pulsed field ablation approach to treating atrial fibrillation, giving it the go-ahead to compete in the emerging sector against heavyweights such as Boston Scientific, Medtronic and Johnson & Johnson.The regulatory green lights—which also include separate agency clearances for its heart-mapping software and other catheter components—help fully unlock Kardium’s war chest. In July, the company raised $250 million in venture capital to prepare for its U.S. commercial launch this year, adding on to the $104 million it obtained in 2024.The Fierce 15 winner’s Globe system is designed to provide single-shot isolations of the pulmonary veins that lead into the heart, which serve as the origin points for most cases of the irregular heartbeat.  Once in place, the catheter expands into a sphere about three centimeters in diameter, which easily nestles into the funnel-shaped openings to the pulmonary veins. It’s studded with 122 individually controllable electrodes that record cardiac activity, measure tissue contact and ultimately deliver pulsed field ablation that disrupts heart muscle cells before damaging other nearby tissues.“The FDA approval of the Globe System represents the most significant milestone in the life of Kardium,” CEO Kevin Chaplin said in a statement. “We are extremely proud of the achievements of the team to deliver on our mission of developing the best treatment for AF. The Globe System supports a personalized, efficient, and effective AF treatment.” In a U.S. clinical trial presented earlier this year, the catheter took an average of about 25 minutes to isolate all four of the heart’s pulmonary veins—with about five total minutes of X-ray fluoroscopy—while touting a 100% procedure success rate and zero device-related complications. After one year, 78% of the 183 treated patients demonstrated freedom from afib.A previous version of the Vancouver-based devicemaker’s Globe system received a European approval in 2020 for delivering traditional thermal ablation.The company has also been exploring the catheter’s ability to create focused and linear ablations to expand its treatment reach as well as its potential to be folded down and redeployed into separate heart chambers to treat atrial flutter, the second-most common arrhythmia after afib.