Medtronic (NYSE:MDT) said today it enrolled the 1st patient in a trial of its Valiant Evo thoracic stent graft system designed for the minimally invasive repair of descending thoracic aortic aneurysms.
The 1st procedure in the trial was performed recently at the Univeristy of Texas Health Science Center at Houston by principal investigator Ali Azizzadeh, Fridley, Minn.-based Medtronic said.
“Medtronic is committed to developing meaningful innovation to deliver better patient outcomes. With the Valiant Evo system, we are leveraging a decade of clinical experience and physician collaboration with the Valiant system, with a lower profile device that may help to treat more complex aortic disease. By listening to physicians we believe that this innovation may support greater access to less invasive treatment options for more patients globally,” aortic biz GM Daveen Chopra said in a press release.
The trial is slated to enroll 100 patients across the U.S. and Europe to test out the low-profile next-gen version of the Valiant system.
The updated version of the device includes and 19F and 20F outer diameter profile for varied size configurations, as well as broader tapered offerings and longer lengths for anatomical customization, the company said.
“The Valiant Evo clinical study has the potential to expand the applicability of thoracic endovascular aortic repair to a wider spectrum of patients,” Azizzade of Texas’ McGovern Medical School at UTHealth said in a prepared statement.
The device is currently cleared under an investigational device exemption with the FDA, Medtronic said.
Earlier today, Medtronic released results from feasibility studies of its new “extravascular” EV-ICD System implantable cardioverter defibrillator designed with leads placed outside the hearts and veins, under the rib cage.
The medical giant touted results from the studies, which it said are the 1st to explore the novel extravascular placement, as showing the device could provide the “same benefits achieved with conventional ICDs.” Data was presented at the Cardiostim / EHRA Eurospace 2016 conference this week.
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