From The Editor | February 14, 2017

Medtronic's CardioInsight, A Nanocoated Stent, And A Hug


By Bob Marshall, Chief Editor, Med Device Online


[click] “What are three great things for your heart, Alex?” – Correct!

Feb. 14 has been Valentine’s Day since the first century, and became associated with romantic love during the 14th century. Thinking about flowers, candy, and cards? (If not, your Valentine’s Day may be in jeopardy.) While you’re thinking, why not explore some good news for the traditional Valentine symbol, the heart?

CardioInsight Blossoms With First Commercial Use In U.S.

Medtronic recently announced FDA clearance of its CadioInsight noninvasive 3D mapping system. The device subsequently had its first commercial use in the U.S. by Dr. Vivek Reddy at Mt. Sanai Medical Center in New York. The CardioInsight system uses a 252-electrode sensor vest that contours to the patient’s body and enables physicians to “see” the source of arrhythmias, aiding in appropriate treatment planning. This noninvasive approach enables cardiac mapping without the need to insert a catheter into the heart via an artery or vein, improving patient safety and reducing the risk of infection.

This was a heart-warming story from the very beginning. CardioInsight (the company) was founded in 2005 by Dr. Charu Ramanathan, and the original ECVUE device — based on her research at Case Western Reserve University — achieved CE Mark approval in 2011, and 510(k) clearances in 2014 and 2015. Along the way, CardioInsight raised $22 million in venture capital to fund operations and was ultimately acquired by Medtronic in 2015 for $100 million. Smart innovation joined with global, market-leading commercialization is always a beautiful arrangement.   

Sweet Success For First Nanocoated Stent Evaluated In U.S.

CeloNova BioSciences has announced the publication of primary endpoint results from its global, 35-center clinical trial evaluating 296 patients with symptomatic ischemic heart disease who were implanted with the first-in-class COBRA PzF NanoCoated Coronary Stent. The 9-month findings were published in the Jan. 23 issue of the Journal of the American College of Cardiology: Cardiovascular Interventions.

The trial was conducted under an investigational device exemption (IDE) from the FDA. As the first nanocoated stent to ever be evaluated in clinical trials in the U.S., the COBRA PzF stent combines a unique, highly deliverable cobalt chromium platform design with a biocompatible Polyzene-F nano-thin polymer. The COBRA, which received CE Mark approval in 2012 and launched in Europe and the Middle East in 2013, addresses an unmet clinical need for patients who may not be candidates for drug-eluting stents or longer term dual-antiplatelet therapy (DAPT), according to principal investigator Dr. Donald Cutlip.

Not to sugar coat this story, but it gets better. Currently, CeloNova is studying further the COBRA PzF stent in the COBRA REDUCE trial. This study will evaluate the safety and efficacy of the COBRA to reduce the need for long-term DAPT in patients (to 14 days) who are at high risk for bleeding, and require treatment for coronary artery disease. A successful outcome in the COBRA REDUCE trial will be even sweeter for patients reducing the 6-month DAPT associated with using a standard FDA-approved drug-eluting stent to 14 days when using the COBRA PzF stent.

If You’ve Forgotten A Card, Just Give A Hug

When all else fails, we go back to square one. In spite of all of the technology and entertainment that fill our world, a research study at the University of North Carolina found a simple solution to heart health. When we enjoy a warm embrace with a loved-one (e.g., a spouse, child, or parent), our bodies release oxytocin, a hormone with the power to lower our blood pressure and reduce stress hormones. Now, this isn’t going to get me out of swimming laps at the YMCA for a little cardio work, but it sure is nice to have a natural prescription for a happy and healthy Valentine’s Day!