New Access Devices Create Gateway To Interventional Structural Heart Disease

Article preview from Start-Up - July, 2012

Now that transcatheter heart valves have been implanted in thousands of humans, it’s becoming clear where the problems lie. Vascular and bleeding complications, stroke and paravalvular leaks are the most troubling consequences. Most of the focus has been on improving the valves and the delivery systems, but now innovators are looking at the issue of access – the particular ways by which therapeutic devices enter the heart – and how it can be changed to improve outcomes. In this issue we profile Apica Cardiovascular, Entourage Medical and Inseal Medical.

New Access Devices Create Gateway To Interventional Structural Heart Disease

Article preview from Start-Up - July, 2012

Start-ups developing vascular or heart-wall access and closure devices improve TAVI and open the doors to future minimally invasive interventions for structural heart diseases.

With any new medical treatment, there are two types of risks: those that are known and anticipated from pre-commercial clinical work, and those that are unknown, can’t be predicted and only emerge once a device or procedure is exposed to real-world clinical practice. New products and procedures start out by being vetted in the protected, false security of clinical trials, involving small numbers of hand-picked patients often treated by leading physicians under ideal circumstances. Only as real-world clinical experience accumulates in large numbers of patients with a multitude of unpredictable co-morbidities and complications do the unanticipated problems begin to emerge.

That’s where TAVI (transcatheter aortic valve implantation) is today. Minimally invasive transcatheter treatments for the aortic valve as an alternative to surgical valve replacement have been available in Europe since 2007 (and in the US since November 2011), and in recent years the number of procedures in Europe has more than tripled, according to a presentation made at this year’s EuroPCR interventional cardiology meeting in Paris in May. Nicolo Piazza, MD, PhD, of the German Heart Center (Munich, Germany) noted that for Europe as a whole, TAVI procedures numbered 4,498 in 2009, 14,599 in 2010 and 18,372 in 2011. To date, an estimated 50,000 patients have been treated in 46 countries. That’s enough time and experience for the cracks in the new procedures to start to show.

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About Start-Up

No publication reviews leading edge companies and technology better than Start-Up. Each issue of Start-Up profiles the most important new product companies, identifies the hottest technology areas, reviews funds flowing into private companies and investment trends, and reports on university tech transfer licensing. Industries covered: pharmaceuticals, biotechnology, medical equipment & devices, and in vitro diagnostics.

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