Medtronic and Biotronik both took steps forward this week with their pacemaker hardware designed to target newly emerging geography in the heart, for delivering electric signals that more closely align with the body’s natural beats.
Medtronic obtained an expanded FDA approval for its OmniaSecure defibrillation lead, opening up its use in the heart’s left bundle branch—where lengths of specialized cells come together to help synchronize the pulses of the left ventricle with the rest of the cardiac muscle.
Known as conduction system pacing, this route can allow clinicians to avoid the blockages sometimes seen with traditional pacing methods, which can interrupt the pacemaker’s signals and can stop the heart’s atria and ventricles from working together efficiently.
Related
Medtronic previously claimed a conduction system pacing green light from the FDA in 2022, for its long-running SelectSecure MRI SureScan Model 3830 pacemaker lead, aimed at another cardiac structure known as the Bundle of His. The OmniaSecure lead works with the company’s implantable cardioverter-defibrillators and cardiac resynchronization therapy defibrillators for preventing sudden cardiac arrest.
“Conduction system pacing is a rapidly growing therapy for patients who need a pacemaker,” Trevor Cook, VP and general manager of Medtronic’s defibrillation solutions business, said in a statement.
“Now, patients who require a defibrillator and pacing have an option that can safely deliver life-saving defibrillation therapy and activate the heart’s natural electrical system to enable a more synchronous, physiologic pattern,” added Cook. OmniaSecure was previously approved by the FDA in January for traditional locations in the right ventricle.
Related
Meanwhile, Biotronik said it recorded the first U.S. commercial procedure for its Solia CSP S lead, designed specifically for left bundle branch area pacing, or LBBAP.
The Solia CSP S, greenlit by the FDA last month, comes tipped with a fixed helix that allows it to screw into the septum of the cardiac muscle that divides its left and right ventricles. Biotronik said its first placement was conducted through New York’s Montefiore Health System.
“[Conduction system pacing] represents the future of physiologic pacing, and Solia CSP S is the first of a new generation of LBBAP-specific solutions,” said Biotronik President Ryan Walters.
Last year, Biotronik sold off its cath lab catalog to Teleflex in a $791 million deal—including its drug-coated balloons and stents, bare-metal scaffolds and the PK Papyrus rescue device for sealing off coronary perforations—to better focus on its electrophysiology portfolio of implantable pacemakers, cardioverter defibrillators, remote heart monitors and spinal cord stimulators.
