SAN FRANCISCO – Less than three years ago, Medtronic (Minneapolis) jolted the med-tech world with the $800 million cash (plus potential earnouts of another $500 million) acquisition of privately-owned, venture capital-funded Ardian (Mountain View, California) (Medical Device Daily, Dec. 1, 2010). Generally unheralded, Ardian had pioneered a catheter-based procedure called renal artery denervation (RDN) for the treatment of resistant hypertension (RH).

SAN FRANCISCO — The proposition that the rate of technological change is accelerating would not excite much dissent, but a session at TCT 2013 highlighted some of the effects of those changes on the world of med tech. Jack Lewin, president/CEO of the Cardiovascular Research Foundation (CRF, New York) addressed how coverage/reimbursement and regulatory review are expected to affect cardiology in the years to come, but his main theme was that the use of big data will soon begin to torque not just how device makers back their claims to payers and regulators, but also how – and whether – regulators and payers approve and pay for devices.