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.
You may also be interested in...
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.
Can "real world evidence" drive consumer health innovation? HBW Insight speaks to Orbital Research’s Chris Bunniss about RWE’s potential for the OTC industry.
Confidence in the vaccine has slipped in the US, regardless of political affiliation.