Medtronic Introduces Aortic and Peripheral Devices in the United States

June 4, 2014—Medtronic, Inc. announced the market expansion of two recently US Food and Drug Administration (FDA)-approved devices. The Valiant Captivia thoracic stent graft system proximal FreeFlo tapers line extension with dissection indication and the Total Across crossing support catheter for peripheral artery disease (PAD) in the below-the-knee (BTK) vessel bed are now available in the United States. Medtronic advised that the devices will be featured at the Society for Vascular Surgery's 2014 Vascular Annual Meeting on June 5 to 7 in Boston, Massachusetts.

According to Medtronic, the Valiant Captivia system proximal FreeFlo tapers line extension is now indicated in the United States for the treatment of thoracic aortic dissections, offering physicians increased patient applicability for fragile, tapered, dissected aortas.

In January 2014, Medtronic initially introduced its 11 new proximal FreeFlo tapered pieces to the Valiant Captivia system. The expanded size matrix enables physicians to treat thoracic pathologies in tapered aortas, increasing the configuration possibilities by 30% to allow for effective treatment of a wider range of patient anatomies.

In the company’s press release, Joseph Bavaria, MD, a national Principal Investigator for the Medtronic DISSECTION trial, commented, “There is a growing body of evidence in support of endovascular repair for thoracic aortic dissection as a minimally invasive alternative to open surgical repair and even medical therapy alone. The Valiant Captivia system has undoubtedly demonstrated safety and efficacy in the treatment of acute type B dissection cases with excellent technical success.” Dr. Bavaria is Professor of Surgery and Director of the Thoracic Aortic Surgery Program at the University of Pennsylvania in Philadelphia, Pennsylvania.

Jean Panneton, MD, added, “In aortic dissection, the aorta tapers significantly. The new Valiant Captivia tapered pieces are ideal for treating these challenging cases, because they offer customizable options. This allows optimal graft sizing that can lead to better procedural outcomes for patients with dissected aortas.” Dr. Panneton is Vascular Surgery Chief and Program Director at Eastern Virginia Medical School in Norfolk, Virginia.

The Total Across crossing support catheter 
is designed to address specific challenges that are encountered by physicians treating patients with critical limb ischemia (CLI) caused by BTK lesions. It is intended to facilitate access of challenging BTK lesions by allowing enhanced support for guidewire advancement, as well as guidewire exchange and selective angiography capabilities. The Total Across device is a 0.014-inch guidewire-compatible crossing support catheter made of a spiral-cut stainless steel hypotube that combines full-length push response with distal flexibility. The device’s catheter x-ray visualization and 2-F tapered tip allow easy access and precise positioning in the most difficult distal lesions. Total Across has European CE Mark approval and recently received US FDA 510(k) clearance.

Anvar Babaev, MD, performed one of the first cases in the United States with the Total Across crossing support catheter. Dr. Babaev, who is an interventional cardiologist at New York University Langone Medical Center in New York, New York, commented in Medtronic’s press release, “CLI with BTK chronic occlusion is a particularly challenging subset of patients to treat, and this patient was no exception having occluded, severely calcified distal anterior tibial artery and large nonhealing foot ulcer. I chose to use the Total Across crossing support catheter, which enabled successful crossing and recanalization of the very difficult lesion with pushability and support I had not experienced before.”

The Total Across crossing support catheter joins the Amphirion Plus and Amphirion Deep percutaneous transluminal angioplasty balloon catheters in Medtronic’s portfolio for BTK interventions. The device is the first of three new products Medtronic plans to introduce that address the clinical challenges associated with the treatment of lower extremity disease, noted the company.