Medtronic announced on November 7th the completion of high-density mapping and dual-energy ablation catheters at St. David's Medical Center---Sphere-9First Commercial RDN CaseChemical surgery. (Sphere-9 was approved for marketing by the FDA on October 25th)PI Evaluation
"This integrated, unprecedented catheter allows doctors to use a single catheter to map, ablate, and verify everything, enhancing workflow flexibility and efficiency, ultimately achieving greater safety and effectiveness. With continuous global innovation in arrhythmia treatment,"St. David's Medical Center"I am very pleased to be able to lead the way for patients in central Texas and beyond."---Andrea Natale St. David's Medical CenterCurrently, the FDA has approved five PFA products for marketing: Medtronic's Sphere-9 Ablation Catheter (Affera Mapping and Ablation System) and PulseSelect, Boston Scientific's Farapulse and Farawave Nav, and Johnson & Johnson's Varipulse. Subsequently, not only will Medtronic, Boston Scientific, and Johnson & Johnson continue to roll out new PFA products,Moreover, companies like Abbott, Kardium, and CardioFocus will also launch their own products to join the PFA battlefield soon.CurrentlyBoston Scientific still has a slight leading edge in the PFA field, but this advantage is gradually being caught up by latecomers. Moreover, each of the three major players has their own strengths as well as weaknesses. For instance, Johnson & Johnson's PFA technology is temporarily lagging, but it possesses the most advanced 3D mapping and ICE, and has the deepest foundation in the electrophysiology field. Boston Scientific, on the other hand, is not only the pioneer of PFA technology but also offers the WATCHMAN, providing a one-stop solution for atrial fibrillation treatment. Medtronic was the first company to receive U.S. approval for PFA and has developed its own 3D mapping system.
The three powers will engage in a life-and-death struggle in the coming decades to gain an advantage. In addition to having reliable technology, they also need to be efficient in commercialization. After all, being able to quickly occupy a blank market is better than engaging in close combat with competitors (Chinese valve companies should have a deep understanding of this).Sphere-9Rapid commercialization will enable Medtronic to take the initiative in the relatively untapped dual-energy PFA market with mapping capabilities, leaving Johnson & Johnson and Boston Scientific to follow.
AfferaIt is an integrated high-resolution mapping and treatment solution that provides more predictable and flexible procedures, enabling physicians...The system enables accurate mapping and ablation using both radiofrequency and pulsed electric field energy through a single transseptal puncture without the need for catheter exchange. The solution includes a mapping/ablation catheter, an energy generator (capable of delivering PFA and RFA), a 3D mapping software (Prism-1), and more.Sphere-9It is the first ablation catheter used in conjunction with the Affera system.It is a 7.5Fr bidirectional steerable catheter with an expandable conductive lattice electrode. The catheter is inserted into the sheath in a folded form, but once inside the heart, the lattice expands into a spherical structure with a diameter of 9mm.The lattice contains 9 micro-electrodes/temperature sensors (diameter 0.7 mm), evenly distributed across its surface.Its effective ablation area is 10 times that of a traditional radiofrequency ablation catheter, completing an ablation in 4-5 seconds, with a radiofrequency ablation lesion width exceeding 19mm and a pulsed electric field ablation lesion width exceeding 17mm.Sphere-9By integrating with Prism-1 software, multiple position sensors can be used at the tip to allow six degrees of freedom for position tracking and constructing a three-dimensional map of the chamber.Conveniently remap, effortlessly switch from ablation to mapping without changing catheters.Sphere-9Combining mapping, navigation, and treatment functions, it is currently the only catheter capable of delivering both radiofrequency and electropulse energy for ablation, allowing physicians to customize treatments based on patient needs during the ablation process.
The IDE clinical study data of Sphere-9 (control group used THERMOCOOL SMARTTOUCH SF with the CARTO mapping system) shows:
The incidence of major safety events was 1.4%, compared to 1% in the control group.
Main Efficiency 74%
80% effectiveness rate > 10 cases
Each surgery saves more than 25 minutes.
Medtronic is one of the largest medical technology, services, and solutions companies in the world, alleviating pain, restoring health, and extending life for millions of people globally. With over 90,000 employees worldwide, Medtronic serves doctors, hospitals, and patients in more than 150 countries. The company is committed to collaborating with stakeholders around the world to advance healthcare.
