Abbot’s Navitor TAVI System Cleared by FDA
Medical device company Abbott’s latest generation TAVI (transcatheter aortic valve implantation) system Navitor, which is used for the treatment of those suffering from severe aortic stenosis, and who are at extreme or very high risk for open heart surgery, has recently been approved by the FDA. “Abbott's Navitor device features advancements to help doctors safely and effectively treat patients with aortic stenosis, including a design that reduces the backflow of blood around the valve that’s often a complication following TAVI procedures,” Michael Reardon, MD, the Alison Family Distinguished Chair of Cardiovascular Research and professor of cardiothoracic surgery at the Houston Methodist Hospital, said in a statement. “The innovative Navitor system also offers physicians stable and accurate device placement, even in challenging patient anatomies.” This new TAVI system provides a less invasive treatment option for common and serious heart diseases for both patients and physicians. Aortic stenosis takes place when the opening of the aortic valve narrows, restricting blood flow, and without treatment, can lead to heart failure, then death. Clinicians could choose to use TAVI therapies, which include the Navitor system, on individuals who are at high risk of surgery, due to complications which could relate to frailty, age, or other medical conditions. “Our Navitor valve builds upon our industry-leading portfolio of minimally invasive devices that surpass existing standards of care to address a range of heart diseases, Michael Dale, senior vice president of structural heart business at Abbott, said in the statement. “Navitor is the first TAVI system to offer optimal hemodynamics in all valve sizes, while also preserving options for lifetime disease management, an important consideration for physicians and patients when selecting a TAVI solution,” he said. “Receiving this approval is a major next step in our mission to help people live better lives through better health.” The Navitor system is equipped with a fabric cuff, to reduce or eliminate blood backflow to the valve frame, known as a paravalvular leak. The Navitor is also the only TAVI system which self-expands containing leaflets within the native valves. This helps to improve access to coronary arteries, and helps future procedures designed for treating coronary artery disease, the company said in a statement. The system has also been applauded for its good hemodynamics (blood flow) through the valve. The FlexNav delivery system is implanted in the Navitor device, and its slim design is used to accommodate various patient anatomies, as well as small vessels for predictive, stable and accurate valve delivery and placement.
First Enrolment For Medtronic’s ADVANCE Trial
Medical device company Medtronic recently announced the first enrolment of a patient in the ADVANCE trial, which is a head to head randomized controlled trial between two aortic stent graft systems. The Medtronic Endurant II/IIs stent graft system is the first, against the Gore Excluder AAA device family stent graft systems. This ADVANCE trial is a global, interventional, prospective, multicentre randomized study which will enrol 550 patients minimum at up at 50 centres around the world. Patients are randomized to receive EVAR (endovascular aneurysm repair) using either the Endurant or Excluder family grafts, which will then be followed at a month, a year, and then annually through the next five years. The first patient to be enrolled in the trial was at Novant Health Forsyth Medical Center, in the USA. “Through the ADVANCE trial, we are working to deepen our evidence of sac regression as a key indicator of long-term EVAR patient outcomes,” said Hence Verhagen, professor of Vascular Surgery at Erasmus Medical Center (Rotterdam, Netherlands) and co-principal investigator of the trial. “Our hope is that the findings will allow physicians to make evidence-based clinical decisions to improve long-term patient outcomes.” The aim of the ADVANCE trial is to further the understanding of sac regression using robust evaluation of CT imaging which utilises an independent core lab over a five year period, providing an aneurysm sac regression outcome comparison between the two stent graft systems. Additional evidence will also be provided to analyse aneurysm-related risk factors for those which fail to regress. The trial also aims to compare certain other key clinical outcomes, which include migration, endoleaks, mortality, secondary intervention and renal complications. “We are pleased to announce the first patient enrolled in the ADVANCE trial,” said Marc Schermerhorn, chief of vascular and endovascular surgery, Beth Israel Deaconess Medical Center (Boston, USA) and co-principal investigator of the trial. “This milestone underscores the commitment to rigorous study of the long-term data around the durability of the Endurant system for patients in need of EVAR. The results of the trial aim to demonstrate contemporary outcomes and our overarching goal to deliver superior aortic patient care through robust and rigorous clinical data.” The ADVANCE trial draws off clinical data which demonstrates that one year sac regression acts as an early indicator of improved long term survival.
Olympus Receives FDA Warning Letters
The company Olympus Medical recently received two letters of warning from the FDA (Food & Drug Administration) regarding safety issues which relate to reprocessing endoscopes, which also involves the cleaning and disinfection of the devices in order that they can be re-used. Throughout inspections which took place in July and September last year (2022), the decision from the FDA was that Olympus failed to provide evidence of adequate testing and recording of the device assembly process. Additionally, the company failed to meet MDR (medical device reporting) standards, according to a statement issued on January 10th from the director of the FDA’s CDHR (Center for Devices and Radiological Health), Jeff Shuren: “CDRH has been involved in extensive and ongoing efforts with Olympus to address compliance issues related to the reprocessing of endoscopes,” Shuren wrote. “However, as described in the recent warning letters, Olympus is not in compliance with MDR reporting and quality system requirements.” These warning letters have been addressed to Aizu Olympus, which is a subsidiary of Olympus Medical Systems and is based in Tokyo. Olympus Medical create a wide range of devices, included among which are duodenoscopes, bronchoscopes, and urological endoscopes. “During recent inspections, [the FDA] determined that Olympus did not meet requirements to assure the quality and performance of the devices such as adequate testing and documentation of the device assembly process,” Shuren said. He also faulted Olympus for not developing reporting procedures to ensure the agency is told of “any infections or reprocessing failures connected to the devices.” In a background statement about endoscope sterilization published this week, the FDA wrote that “inadequate cleaning between patient uses can result in the retention of blood, tissue and other biological debris (soil) in certain types of reusable medical devices.” Olympus issued an emailed statement, saying that it is currently working with the FDA: “Comprehensive responses to each Warning Letter have been submitted to FDA on time, and the implementation of appropriate actions to address the FDA’s concerns is progressing on time,” Olympus said. “The company is committed to implementing sustained improvements to its Quality System to ensure that we consistently meet requirements and are in full compliance with regulations.”
Enrollment Completed in Pivotal Medtronic Ablation Catheter Trial
Medical device company Medtronic recently announced that enrolment and final treatment had been completed in the SHPERE Per-AF Trial, a US FDA (Food and Drug Administration) IDE (Investigational Device Exemption) trial which was designed for safety and effectiveness evaluation of the Sphere-9 first-of-its-kind catheter for pulsed field, radiofrequency ablation and high-density mapping, with the Affera mapping and cardiac navigation platform used for treating persisting AF (atrial fibrillation). The Affera platform, which is designed to improve efficiency, enables intuitive high definition mapping, in order to diagnose arrhythmias while treating patients with just one catheter. The Sphere-9 combines therapeutic, navigation and mapping capabilities, and is the only existing catheter which can deliver both RF energies and PF energies for ablation. This provides physicians with an ability to customize treatment around a patient’s needs throughout an ablation procedure. "During the trial, my observations and experience with the novel Affera system have been very promising," said Devi Nair, M.D., FHRS, Director of Cardiac Electrophysiology & Research, St. Bernards Medical Center, Jonesboro, Arkansas, a participating site in the SPHERE Per-AF trial. "Unlike conventional technologies, I've been impressed with the ability to both map and ablate with the option of dual energy sources, with one catheter. I look forward to the results of the trial and remain optimistically enthusiastic as I continue to understand the safety and efficacy of the Sphere 9 ablation catheter." The SPHERE Per-AF Trial is a multicenter, global and prospective randomised clinical trial. Since it began in December 2021, it has enrolled 477 patients suffering with persistent AF, spanning 23 centres in Europe and the US. Patients will undergo assessment over 12 months to ensure safety and efficacy. "Treating the final patient in the fast-moving SPHERE Per-AF Trial builds on the exciting phase of innovation and growth at Medtronic over the last year, including the acquisition of Affera, our agreement to distribute a differentiated portfolio of left-heart access tools and devices to support a zero-exchange procedure workflow, and the continued progress in the development of PulseSelect, our organic PFA system," said Rebecca Seidel, president, Cardiac Ablation Solutions business, which is part of the Cardiovascular Portfolio at Medtronic. "Thanks to the innovation and expertise within Affera and the support of our Medtronic team, together we're able to continue to evaluate new, best-in-class solutions and commercialize a full, comprehensive portfolio to help physicians treat patients around the world." Acquired by Medtronic in August 2022, the Affera product portfolio is not, at present, currently approved or available for either sale or commercial use.