Startup Medical Devices Change the World

RDN Procedure 2 - Catheter-based Energy DeliveryIn case you aren’t paying attention, novel medical devices are changing the world. Some recent clinical trial headlines:

Ardian’s Renal Denervation System Demonstrates Sustained Blood Pressure Reduction at 30 Month Follow Up

Asthmatx Bronchial Thermoplasty Provides Long Term Asthma Control Out to 5 Year Follow Up

Percutaneous Valve Technologies’ and CoreValve’s Real World Registry Data Show That Transcatheter Valves Dramatically Improve New York Heart Association class III/IV symptoms and Angina

Barrx’s Endoscopic Ablation Therapy Eliminates Precancerous Esophageal Tissue and Significantly Reduces Disease Progression In Patients with Low Grade Dysplasia

EndoGastric Solutions’ Incisionless Endoscopic Procedure Significantly More Effective at Eliminating Chronic GERD Symptoms than Maximum PPI Dose, New Data Show

CV Ingenuity’s drug-eluting balloon demonstrates good 12 month efficacy in peripheral arterial disease.

Making a real and lasting impact – that’s what medical device startups are all about.

That’s why I do what I do.

Ethics and Options in Clinical Trial Design

Newspaper advertisements seeking patients and ...
Image via Wikipedia

You can’t help but be moved by the plight of the patients in Saturday’s NY Times article “New Drugs Stir Debate on Rules of Clinical Trials.” The article caused me to reflect on my role, as a medical device executive, in the design of clinical trials.  The story presents the ethical challenges of a randomized controlled clinical trial (RCT) of a new drug, through the story of two patients in the trial.  The same challenges faced by drug trials also apply to medical device trials.   What are some of the issues and what are some of the options?

Continue reading “Ethics and Options in Clinical Trial Design”

Coronary Artery Bypass Graft Surgery Report Puts Registries in the Spotlight

Yesterday, Consumers Union published quality rankings of 221 of 1,100 cardiac surgery programs in the US.  If you haven’t already, I encourage you to read the New England Journal of Medicine and New York Times coverage.  The underlying data come from a clinical registry developed by the Society of Thoracic Surgeons, and managed by Duke Clinical Research Institute.  I expect to see registries used more commonly  for the clinical, regulatory and market development of new medical devices.

Continue reading “Coronary Artery Bypass Graft Surgery Report Puts Registries in the Spotlight”