MASSDEVICE ON CALL — A new study out of Brigham & Women’s Hospital in Boston suggests that transparency rules might have negative consequences for very sick heart patients.
The study evaluated the frequency of coronary stent implantation in 116,227 Bay State patients, finding that "outlier" hospitals – pegged for having higher-than-average death rates – were less likely to accept the sickest patients.
Study author Dr. James McCabe stressed that his findings don’t clearly prove doctors shied away from stenting very sick patients. But the study raises the issue of unintended consequences when it comes to transparency rules.
"It really does highlight the idea that [for] all the good that has come from public reporting and process improvement, we’ve traded that for another set of problems," Dr. Duane Pinto, director of the cardiac ICU at Beth Israel, told the Boston Business Journal.
Scanadu crowdsources $1M
Scanadu landed $1 million and extended the crowd-sourced funding campaign for its Scout medical tricorder device. The smartphone-enabled medical diagnostic tool company’s Scout device is a personal body scanner that sends vital signs to a smartphone application. The device is not yet FDA approved, and the company has extended its crowdsourcing campaign, called Indiegogo, for 1 month.
Sorin Group launches Respond CRT trial
Sorin Group’s Respond CRT clinical trial kicked off this week, with the 1st patient implanted with the Italian medical device company’s Paradym SonR CRT system. In March, the FDA granted investigational device exemption for the trial of the heart resynchronization device. Sorin touts SonR as the first to automatically adjust its settings on a weekly basis.
Mauna Kea Technologies inks ACMO deal in Japan
Mauna Kea signed a distribution deal in Japan with AMCO, a critical step before the company can sell its Cellvizio optical biopsy product in the Land of the Rising Sun. Japanese regulators require companies to either have a brick-and-mortar presence or to partner with a local distributor before putting products on the market.
KCI kicks off negative-pressure wound therapy trial
Kinetic Concepts Inc. launched a trial to compare traditional negative pressure wound therapy to its VAC VeraFlo Instillation therapy. The trial will involve 6 medical centers in the U.S. and will treat patients with serious wounds needing surgical attention. The company is hoping to see a reduction in hospital stay and OR visits for patients treated with the new VAC system.