Edwards Lifesciences has launched a new mitral valve repair therapy designed to treat the leaky mitral valve of patients suffering from congestive heart failure. The Edwards GeoForm annuloplasty ring, which features a unique, 3D shape, has been shown to successfully treat mitral valve regurgitation caused by cardiomyopathy, and improve the function of the left ventricle, according to a presentation delivered at the annual meeting of the European Association for Cardio-Thoracic Surgery (EACTS).
In his presentation, "GeoForm: A New Valvular Solution for a Ventricular Problem", Dr Steven F Bolling, Professor of Surgery and Director of the University of Michigan Health System's Mitral Valve Clinic, presented results from a prospective study of 16 congestive heart failure patients, all of whom were suffering from mitral valve regurgitation due to distortion of their heart's left ventricle. Six months after the patients' mitral valves were surgically repaired with the Edwards GeoForm annuloplasty ring, their mitral valve regurgitation, or backflow of blood caused by a leaking valve, was eliminated and the left ventricle was reformed. Edwards Lifesciences developed the GeoForm ring with Professor Ottavio M Alfieri, St Raffaele Hospital in Milan, Italy and Bolling (see EACTS report).
"While still early, these results clearly demonstrate excellent outcomes for patients suffering from severe mitral valve regurgitation and left ventricular dysfunction," said Bolling. "We believe this heart valve repair ring will help break the cycle of mitral valve regurgitation and left ventricular distortion that can be caused by certain forms of congestive heart failure."
"The data validate what we've believed all along: a large untreated population of heart valve patients could be helped by undergoing earlier heart valve repair," said Anita B Bessler, Edwards' Corporate Vice President of Global Franchise Management. "This is why we remain so committed to pioneering innovative heart valve therapies designed to specifically treat the large number of unaddressed patients."
Separately, St Jude Medical has launched the Epicor Cardiac Ablation System, which features a unique high intensity focused ultrasound (HIFU) energy source, which enables physicians to create continuous transmural ablative lesions safely and reproducibly, without the need to put patients on a heart-lung (cardiopulmonary) bypass machine.
Results of a prospective multi-centre study using the Epicor Cardiac Ablation System were published in the September 2005 issue of the Journal of Thoracic and Cardiovascular Surgery (JTCVS). The study showed that at six-month follow-up, 85% of patients in the study group remained free from atrial fibrillation (AF) (80% in patients with permanent AF, 88% in patients who received an additional mitral line and 100% in patients with paroxysmal AF).
In addition, the company also introduced the Rigid Saddle Annuloplasty Ring, the only annuloplasty ring designed to approximate the mitral valve's natural, 3D saddle shape, resulting in less stress on the valve's leaflets and chords.
With its anatomical shape and versatility for either ischaemic or degenerative disease, this ring provides surgeons with a durable annuloplasty repair alternative, further expanding
St Jude Medical's portfolio of repair solutions for cardiac surgeons worldwide.
The company also highlighted several other cardiac surgery products at EACTS, including:
The St Jude Medical Masters HP Valved Graft with Gelweave Valsalva technology, designed to simultaneously repair the damaged portion of the ascending aorta and replace the aortic valve during heart valve replacement surgery. This innovative device combines the exceptional haemodynamic performance of the Masters HP valve with the advantages of the Vascutek (a Gelweave Valsalva graft, which is designed to replicate the aorta for easier implantation and provide excellent haemostatic control.
The Epic and Epic Supra stented valve system featuring the FlexFit Stent for ease of implant and the proprietary Linx anti-calcification technology forenhanced durability of the valve. In July 2005, the Journal of Heart Valve Disease published a peer-reviewed article entitled "Seventeen-Year Experience with the Biocor Porcine Bioprosthesis", by Dr Pia Myken of Sahlgrenska University Hospital, Gothenburg, Sweden, which highlighted the Biocor valve's excellent durability in both the aortic and the more challenging mitral positions, as well as its ease of implantation. The Epic and Epic Supra are the next generation of valves based on the Biocor stented valve system.
The Regent mechanical heart valve, the company's most advanced mechanical valve, has set a standard in haemodynamic performance never before seen in the mechanical heart valve market. This valve offers the traditional quality and durability.
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