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Beyond Bypass: Next Generation Coronary Revascularization

This article was originally published in Start Up

Executive Summary

Traditional coronary artery bypass graft (CABG) surgery has been refined to be the most effective long-term treatment for occluded coronary arteries. Yet it remains a major surgical procedure that is traumatic for patients. Various minimally-invasive approaches to cardiac surgery have been developed but adoption rates are slow because these new procedures don't yet measure up to traditional CABG and because heart surgeons are slow adopters of new technology. Recent discoveries in coronary physiology have opened the door for new approaches to creating cardiac perfusion in a patient with occluded vessels. But this requires physicians to re-think what they were taught in medical school. One such approach, which involves direct vascularization from the ventricle, is being pursued by three companies: Percardia, HeartStent and Ventrica. Another company, TransVascular, is taking a broader approach by using the venous system to bypass arterial blockages. Approaches that require physicians to think differently about basic science, along with the tortuous clinical and regulatory path for new cardiac surgery devices and the cautious nature of cardiothoracic surgeons, present significant challenges to these start-up companies.

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The Death of Investing in Heart Surgery: An Exaggerated Demise

Over the past several years, new tools have helped interventional cardiologists capture patients who historically would have been candidates for surgery. Drug-eluting stents are apt to only increase this trend. These technology innovations have sparked the latest round of proclamations that there is no future in cardiac surgery since the sector's largest component--bypass--is waning, and that the only worthwhile coronary device investment opportunities lie in products with interventional applications. Yet cardiac surgery remains a major device opportunity. A significant increase in M&A activity and recent later-round financings by companies like Percardia and Converge indicate that investing in cardiac surgery start-ups remains alive and well, albeit with new challenges. Indeed, some investors believe that heart surgeons, traditionally conservative adopters of new technology, are now more receptive than ever to new devices and procedures because of the threat to their livelihoods posed by interventionalists' increased encroaching on surgeons' core patients.

The Death of Investing in Heart Surgery: An Exaggerated Demise

Over the past several years, new tools have helped interventional cardiologists capture patients who historically would have been candidates for surgery. Drug-eluting stents are apt to only increase this trend. These technology innovations have sparked the latest round of proclamations that there is no future in cardiac surgery since the sector's largest component--bypass--is waning, and that the only worthwhile coronary device investment opportunities lie in products with interventional applications. Yet cardiac surgery remains a major device opportunity. A significant increase in M&A activity and recent later-round financings by companies like Percardia and Converge indicate that investing in cardiac surgery start-ups remains alive and well, albeit with new challenges. Indeed, some investors believe that heart surgeons, traditionally conservative adopters of new technology, are now more receptive than ever to new devices and procedures because of the threat to their livelihoods posed by interventionalists' increased encroaching on surgeons' core patients.

TransVascular: Re-Tooling After Clinical Failure

After a major setback in clinical trials of a lead product, many start-ups fail. But TransVascular Inc. has not only survived, it is starting clinical trials with a revised device and developing new applications for its technology. The TransAccess System, the company's core technology, is a coronary revascularization device that ran into problems when its trial was discontinued due to severe adverse coronary events. Transvascular believes it found the problem and has developed a solution--a better guidance system and blocking device. Now, its new PICVA system is scheduled to be used shortly on several patients in Europe.

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