A Medical Device Daily

Hansen Medical (Mountain View, California) is showcasing its new generation robotic technology, designed for accurate and stable control of catheter movement during cardiac procedures, at the 12th annual international Boston Atrial Fibrillation (AF) Symposium, which began yesterday and continues through Saturday in Boston.

The symposium is a meeting of leading electrophysiologists in the field of arrhythmia and AF management from around the world with this year’s theme “Mechanisms and New Directions in Therapy.” It is being held at the Seaport Hotel & Conference Center at the World Trade Center.

Hansen’s Sensei Robotic Catheter System is designed to guide catheters for mapping heart anatomy during treatment of patients suffering from arrhythmias.

The company recently reported the completion of a 20-patient prospective trial and seven-day follow-up using the Sensei system to guide catheters for mapping heart anatomy, a critical step in identifying heart tissue that generates abnormal heart rhythms. Data from the follow-up showed no device-related adverse events, and is being prepared as part of a submission to the FDA in support of a 510(k) currently under review, the company said.

“The new robotic catheter system has the potential to fundamentally change the way electrophysiology procedures are performed worldwide and make it possible for a broader group of physicians to perform complex cardiac procedures such as cardiac arrhythmia mapping,” said Wyn Davies, MD, FRCP, FHRS, consultant cardiologist, St. Mary’s Hospital (London), and principal investigator of the clinical trial.

The company says that, currently, cardiac electrophysiology procedures are performed using a manual technique that requires physicians to perform a series of complex manipulations at one end of the catheter with inadequate assurance that the tip of the catheter will respond as desired while inside a patient’s heart. As a result, achieving stable contact at every anatomic site within the heart necessary for successful mapping can be difficult. Insufficient contact between the catheter tip and the inside of the heart wall can lead to highly variable and less than optimal procedure outcomes.

“There is a medical need for broader use of catheter-based procedures for diseases where catheters are rarely used today, and we believe our robotic platform will enable more physicians to perform complex interventional procedures through greater ease of use, and possibly improve patient outcomes,” said Frederic Moll, MD, founder and CEO of Hansen Medical, which was founded in 2002.

The new technology incorporates fluoroscopic, intracardiac ultrasound, 3D surface map and patient electrocardiogram data into one portable workstation. The workstation can be easily moved among catheter lab suites and does not require costly construction of a specialized room.

To date, the company reports 83 cardiac procedures have been performed on patients in Europe using the Sensei Robotic Catheter System.

In other news from the conference:

St. Jude Medical (St. Paul, Minnesota) reported FDA clearance and CE-mark approval of its Reflexion Spiral Variable Radius Mapping Catheter and a faster, smaller EnSite System workstation computer. St. Jude is showcasing these products for the first time at the symposium.

The Reflexion Spiral Variable Radius features a circular loop at the tip that expands from 15 mm to 25 mm to fit a variety of patient anatomies. It is the only variable radius circular mapping catheter available with bi-directional deflection, which provides enhanced versatility for complex left atrial procedures, St. Jude said.

It also features the company’s ComfortGrip handle to give physicians improved comfort and control during electrophysiology (EP) procedures.

One of the first physicians to use this product, Andrea Natale, MD, of the Cleveland Clinic (Cleveland, Ohio) said, “The ability of the catheter to deflect in both directions is a very useful benefit, and the handle proved extremely comfortable and easy to use.”

The EnSite System provides detailed 3-D cardiac models that help physicians diagnose and treat many arrhythmias, including AF. The system is now available with a new computer, featuring twin dual-core processors for a dramatic improvement in processing speed.

Many of the most complex processing and image rendering times have been reduced by up to 80%, the company said, allowing clinicians to obtain, display and analyze information faster than ever.

“The Boston Atrial Fibrillation Symposium brings together clinicians from around the world who are driving the innovation of curative approaches for this challenging and widespread condition,” said Jane Song, president of the Atrial Fibrillation Division of St. Jude Medical. “We look forward to collaborating with these leaders to develop technologies, procedures and clinical studies that support effective treatment of complex arrhythmias, including atrial fibrillation.”

At the 2007 Boston AF Symposium, St. Jude will also sponsor an educational symposium: “Evolving Approaches: The Next Generation of AF Management,” chaired by Warren Jackman, MD, of the University of Oklahoma (Oklahoma City) and Douglas Packer, MD, of the Mayo Foundation (Rochester, Minnesota).