A lot of different things went into making human beings the most significant species ever, but that being said, none made a bigger contribution to it than our ability of growing on a consistent basis. This ability, in particular, has already brought the world some huge milestones, with technology appearing as a major member of the stated group. The reason why technology enjoys such an esteemed stature among people is, by and large, predicated upon its skill-set, which ushered us towards a reality that nobody could have ever imagined otherwise. Nevertheless, if we look up close for a second, it will become clear how the whole runner was also very much inspired from the way we applied those skills across a real world environment. The latter component was, in fact, what gave the creation a spectrum-wide, and consequentially, kickstarted a tech revolution. Of course, this revolution then went on to scale up the human experience through some outright unique avenues, but even after achieving such a monumental feat, technology will somehow continue to produce the right goods. The same has grown increasingly evident over the recent past, and assuming one new healthcare-themed development shakes out just like we envision, it will only make that trend bigger and better moving forward.
Medtronic, a global leader in healthcare technology, has officially secured an approval from the US Food and Drug Administration for its Pulsed Field Ablation (PFA) System called PulseSelect, which is designed to treat both paroxysmal and persistent atrial fibrillation (AF). According to certain reports, the PulseSelect PFA system comes decked up with an ability to deliver rapid and effective pulmonary vein isolation (PVI) through consistent and predictable energy delivery and catheter maneuverability. The system also knows a thing or two about facilitating a smooth transition to PFA in a clinician’s preferred workflow. Complimenting the same is how PulseSelect’s safety, efficacy, and efficiency is also reinforced by a specialized PULSED AF study, where it was revealed that the device features a 0.7% safety event rate, alongside a clinical success rate of 80% in both paroxysmal and persistent AF patients. Now, before we get any further into the device, we must acknowledge the severity of the condition it is trying to solve. You see, more than 60 million people worldwide are diagnosed with atrial fibrillation every year. Another detail worth a mention is the disease’s progressive nature; meaning if left unaddressed or given a substandard quality of treatment, it can get worse over time and result in serious complications including heart failure, stroke, and increased risk of death. Now, we do have a set of existing technologies to treat that risk, but almost all those technologies rely on thermal effects to target cardiac tissue, and therefore, carry a huge risk of damaging other collateral structures in the heart. The new PFA device, however, stands out by using pulsed electric fields to efficiently isolate the pulmonary veins for the treatment of AF.
“The PulseSelect PFA system ushers the EP community to a new era of safe, effective, and efficient AF ablation that overcomes many challenges in our current practice,” said Dr. Amin Al-Ahmad, clinical cardiac electrophysiologist at St. David’s Medical Center in Austin, TX, and one of 67 global operators in the PULSED AF trial. “In my clinical experience with the catheter, it was designed for AF ablation procedures. The learning curve in using the catheter and system is short, and the catheter enables the operator to deliver fast and controlled pulsed field energy for AF ablation.”
Talk about the device on a slightly deeper level, it is, for starters, made like plug-and-play system. This allows you to use PulseSelect with any mapping system or with just fluoroscopy. Next up, we must acknowledge the built-in safety features, an assortment headlined by phrenic nerve test pulse, which is a non-therapeutic low voltage pulse that provides a preemptive assessment of catheter proximity to the phrenic nerve before delivering a therapeutic application. Then, there is fixed spacing for the nine-electrode catheter, positioned to manufacture a predictable and consistent electric field for ablation. Interestingly, beyond ablation, these nine electrodes can also be used for pacing and sensing. Rounding up the highlights is a small 9Fr bidirectional catheter, which scales up maneuverability and access to various anatomical structures, and at the same time, stays compatible with a 10Fr sheath, including the custom bidirectional FlexCath Contour™ sheath.
Founded back in 1949, Medtronic has today reached a point where it boasts a team of well over 95,000 people, stretching across 150 countries. At present, the company’s line-up of solutions include cardiac devices, surgical robotics, insulin pumps, surgical tools, and patient monitoring systems etc, all coming together to treat an estimated total of 70 different health conditions.
“We are thrilled to see the continuous innovation of our legacy Cryoablation portfolio alongside the approval of the PulseSelect PFA system in the U.S.,” said Khaldoun Tarakji, MD MPH, Chief Medical Officer of the Cardiac Ablation Solutions business at Medtronic. “Every patient deserves the best care. What motivates all of us at Medtronic is the privilege of serving patients by empowering electrophysiologists globally with the safest and most effective ablation technologies that seamlessly integrate with their workflows and enable them to tailor therapy based on their patients’ needs.”
