Medtronic (MDT) demonstrated proof of concept for its Valiant Mona LSA branch thoracic stent graft system. The medical device company announced the results of its “Innovation Pathway” feasibility pilot study Wednesday at the VEITHsymposium. In the seven patients in the study, the company touted “100 percent technical success and 100 percent patency in both main and branch stent graft. There were no type I or III endoleaks,” according to a statement.
“This new technology could potentially minimize the need for invasive surgery and extend the benefits of endovascular repair without additional surgery to more patients with thoracic aortic aneurysms,” Dr. Frank Arko, one of the study’s U.S. investigators, said in a press release.
“Thoracic aortic aneurysms involving branch vessels such as the LSA can be particularly challenging to treat,” Dr. Eric Roselli, a cardiothoracic surgeon at the Cleveland Clinic and the study’s national primary investigator, said in a press release. “The Valiant Mona LSA system could help address an unmet need in the treatment of thoracic aortic aneurysms. This is clearly reflected in the FDA’s decision to help advance the development of this new therapy.”
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The device is one of the nine first selected as part of the FDA’s Innovation Pathway, a program that aims to encourage early-stage clinical investigation for medtech.
According to a company statement:
The Valiant Mona LSA system is designed to enable endovascular repair of thoracic aortic aneurysms encroaching on the left subclavian artery (LSA) by excluding the aneurysm from blood flow while maintaining perfusion of the LSA. Based on the market-leading Valiant Captivia thoracic stent graft, the investigational system features a branch cuff that accommodates the LSA branch graft.
The device, if successful, would eliminate the need for LSA bypass surgery in patients with a thoracic aortic aneurysm. Now, about 40 percent of those patients “where coverage of the LSA is required to achieve a seal zone with the stent graft” must undergo that surgery.
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