11.26.14
Sorin Group has received U.S. Food and Drug Administration (FDA) approval for the Solo Smart Aortic Pericardial Heart Valve.
The company claims Solo Smart is the first valve with a removable stent to be approved in the U.S. market. Designed from bovine pericardium, the valve is fully biological with no synthetic material added. This bioprosthesis mimics the healthy native aortic valve in order to preserve the aortic root physiology. By aligning to the patient’s annulus with a 100 percent orifice-to-annulus ratio, Solo Smart maximizes blood flow and delivers excellent hemodynamic performance, Sorin Group said.
“We are pleased to provide patients and cardiothoracic surgeons in the US with the Solo Smart valve, a technology that offers superior hemodynamics and clinical outcomes”, said Michel Darnaud, president of Sorin's Cardiac Surgery Business unit. “This is an important milestone for Sorin Group.”
The removable Ni-Ti alloy stent sets Solo Smart apart from all other valves, as this feature provides support during implantation and is then completely removed, according to the company. The removable stent along with the single-suture line implant technique reduces the time spent seating and suturing the valve. The prosthesis is treated for the elimination of aldehyde residuals so it is not necessary to rinse the valve before implantation. Once the stent is removed following implantation, Solo Smart becomes an entirely stentless valve, providing low pressure gradients and large orifice areas.1
Solo Smart is the evolution of the Freedom Solo valve, which has been implanted in international markets since 2004. This valve has been evaluated in numerous clinical studies representing over 4,000 patients with follow-up to eight years.
“I am very excited to begin implanting the Solo Smart valve, said David Heimansohn, M.D., of St. Vincent Heart Center in Indianapolis, Ind., who participated in the U.S. investigational device exemption clinical study. “Solo Smart is the closest bioprosthesis to the native aortic valve and allows me to offer my patients a solution that provides superior hemodynamics while reducing the length of surgery”.
Reference:
1. A. Repossini, M. Rambaldini, V. Lucchetti, U. Da Col, F. Cesari, C. Mignosa, E. Picano and M. Glauber; Eur J Cardiothorac Surg. 2012;41(5):1104-111.
Sorin Group is a global medical device developer, manufacturer, and marketer of medical technologies for cardiac surgery and the treatment of cardiac rhythm disorders. With more than 3,500 employees worldwide, the Company focuses on two major therapeutic areas: cardiac surgery (cardiopulmonary products for open heart surgery and heart valve repair or replacement products) and cardiac rhythm management (pacemakers, defibrillators and non invasive monitoring to diagnose arrhythmias and deliver anti-arrhythmia therapies as well as cardiac resynchronization devices for heart failure treatment).
The company claims Solo Smart is the first valve with a removable stent to be approved in the U.S. market. Designed from bovine pericardium, the valve is fully biological with no synthetic material added. This bioprosthesis mimics the healthy native aortic valve in order to preserve the aortic root physiology. By aligning to the patient’s annulus with a 100 percent orifice-to-annulus ratio, Solo Smart maximizes blood flow and delivers excellent hemodynamic performance, Sorin Group said.
“We are pleased to provide patients and cardiothoracic surgeons in the US with the Solo Smart valve, a technology that offers superior hemodynamics and clinical outcomes”, said Michel Darnaud, president of Sorin's Cardiac Surgery Business unit. “This is an important milestone for Sorin Group.”
The removable Ni-Ti alloy stent sets Solo Smart apart from all other valves, as this feature provides support during implantation and is then completely removed, according to the company. The removable stent along with the single-suture line implant technique reduces the time spent seating and suturing the valve. The prosthesis is treated for the elimination of aldehyde residuals so it is not necessary to rinse the valve before implantation. Once the stent is removed following implantation, Solo Smart becomes an entirely stentless valve, providing low pressure gradients and large orifice areas.1
Solo Smart is the evolution of the Freedom Solo valve, which has been implanted in international markets since 2004. This valve has been evaluated in numerous clinical studies representing over 4,000 patients with follow-up to eight years.
“I am very excited to begin implanting the Solo Smart valve, said David Heimansohn, M.D., of St. Vincent Heart Center in Indianapolis, Ind., who participated in the U.S. investigational device exemption clinical study. “Solo Smart is the closest bioprosthesis to the native aortic valve and allows me to offer my patients a solution that provides superior hemodynamics while reducing the length of surgery”.
Reference:
1. A. Repossini, M. Rambaldini, V. Lucchetti, U. Da Col, F. Cesari, C. Mignosa, E. Picano and M. Glauber; Eur J Cardiothorac Surg. 2012;41(5):1104-111.
Sorin Group is a global medical device developer, manufacturer, and marketer of medical technologies for cardiac surgery and the treatment of cardiac rhythm disorders. With more than 3,500 employees worldwide, the Company focuses on two major therapeutic areas: cardiac surgery (cardiopulmonary products for open heart surgery and heart valve repair or replacement products) and cardiac rhythm management (pacemakers, defibrillators and non invasive monitoring to diagnose arrhythmias and deliver anti-arrhythmia therapies as well as cardiac resynchronization devices for heart failure treatment).