Dive Brief:
- Kardium has received premarket approval for its Globe pulsed field ablation system, as well as 510(k) clearances for both the Globe Introducer sheath and mapping software, the company said Wednesday.
- The Food and Drug Administration authorization positions Kardium, which raised $250 million to fund commercialization in July, to launch the system as a treatment for atrial fibrillation.
- Kardium is entering a fast-growing market served by Boston Scientific, Johnson & Johnson and Medtronic. The company cited Boston Scientific and Medtronic devices as 510(k) predicates.
Dive Insight:
Kardium’s pulsed field system maps and stimulates cardiac tissue to treat AFib. Kardium named Medtronic’s Affera as the predicate for its pulsed field system. Boston Scientific’s Faradrive, which is used to deliver the Farawave PFA catheter, served as the predicate device for Kardium’s introducer sheath.
When deployed, the Globe system has a spherical array of 122 electrodes that map the environment and deliver PFA to ablate tissue. Users can focus energy delivery on electrodes that are in contact with tissue.
A pivotal trial linked the system to a 78% one-year rate of freedom from atrial arrhythmia in paroxysmal AFib patients. The Mount Sinai Fuster Heart Hospital’s Vivek Reddy, who presented the data in April, told the Heart Rhythm Society’s media outlet that the result reflected pulmonary vein isolation durability. The trial found 95% of veins remained durably isolated.
Kardium is marketing the device as providing rapid and durable single-shot PVI. Medtronic’s Pulseselect is a single-shot system but it lacks mapping capabilities. When Medtronic won approval for its integrated system Affera last year, Stifel analysts contrasted the device’s point-by-point ablation to the single-shot, de novo ablation of Boston Scientific’s Farapulse. Affera can deliver PFA or radiofrequency energy.
Sales of Boston Scientific’s and Medtronic’s devices have grown quickly. Medtronic reported 50% global growth of its cardiac ablation systems last month and predicted growth will accelerate as PFA supply expands in the coming quarters. Boston Scientific reported 96% growth at its electrophysiology unit in July.
Kardium secured funding to challenge the incumbents in July. The company raised a $250 million round to expand its manufacturing capabilities and establish a clinical support and commercial team to support the launch of its system this year.
