MiRus Siegel™ TAVR US Early Feasibility Study (EFS) 30 Day Results Presented at NY Valves Meeting
In the US EFS, 15 patients with severe, symptomatic aortic stenosis (AS) were treated at Piedmont, Cedars Sinai, Stanford, Mayo Clinic and Naples. At 30 days, there were no deaths, strokes or re-hospitalizations. No patients had vascular complications, PVL (> moderate) or required a permanent pacemaker. Core lab echocardiographic data demonstrated a mean gradient of 6.3 mmHg, and valve area of 2.8 cm2 .
The Siegel valve represents several firsts in TAVR: 8 French delivery sheath allowing less invasive procedures and broader patient access, particularly for women; the only Nickel-free THV allowing treatment of the 20% of Americans suffering from Nickel allergies; precise delivery due to lack of foreshortening and intrinsic commissural alignment; dry porcine pericardial leaflets with anti-calcification treatment and with the valve pre-mounted on the balloon.
'This is the first TAVR to have no foreshortening during implantation and along with small vascular access, makes it very user friendly and should also lead to fewer pacemakers and vascular complications' commented Pradeep K. Yadav, MD. 'The lack of nickel is also very appealing – we were able to treat a patient with severe nickel and cobalt allergy.'
The combination of low delivery system profile and excellent hemodynamics is made feasible by the unique properties of the Rhenium alloys pioneered by MiRus including high yield strength, fatigue resistance and minimal recoil.
'The gradients and valve areas with the Siegel valve are outstanding' stated Raj R. Makkar, MD. 'Valve placement is very precise and allows us to protect the conduction system – one of our patients was quite elderly with pre-existing conduction system injury and we were able to replace his valve without having to place a permanent pacemaker.'
About MiRus, LLC.
MiRus is a life sciences company headquartered in Marietta, Georgia that has developed and is commercializing proprietary novel biomaterials, implants and procedural solutions for the treatment of spine, orthopaedic and structural heart disease. Inspired by the pioneering material science of NASA for rocket engines, MiRus has created Rhenium based medical alloys that are transforming medicine by making surgeries less invasive and implants safer and more durable. Find out more information about MiRus at www.mirusmed.com.
Statements made in this press release that look forward in time or that express beliefs, expectations or hopes regarding future occurrences or anticipated outcomes are forward-looking statements. A number of risks and uncertainties such as risks associated with product development and commercialization efforts, expected timing or results of any clinical trials, ultimate clinical outcome and perceived or actual advantages of the Company's products, market and physician acceptance of the products, intellectual property protection, and competitive offerings could cause actual events to adversely differ from the expectations indicated in these forward looking statements. The Siegel TAVR system is an investigational device and not FDA approved.
* MiRus® , Siegel™ are all trademarks of MiRus, LLC.
Contact:
Pam Cowart
VP of Clinical Affairs
[email protected]
770-861-4804
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