STEREOTAXIS NEWS · STEREOTAXIS NEWS SEPTEMBER 2015 VOLUME 1 ISSUE 3 ... The symposium was chaired by ... Safety & Clinical Outcome of Catheter Ablation of Ventricular Arrhythmias

STEREOTAXIS NEWS VOLUME 1 ISSUE 3SEPTEMBER 2015

Questions? Contact [email protected]

JAPAN HEART RHYTHM SOCIETY (JHRS)July 28-31 (Kyoto, Japan)

Stereotaxis hosted a lunch seminar during the 30th Annual Meeting of the Japan Heart Rhythm Society titled “Catheter Ablation of Complex Arrhythmia Using Magnetic Catheter Maneuvering System”. The symposium was chaired by Dr. Yoshito Iesaka (Tsuchiura Kyodo Hospital, Japan) and presented by Dr. Hiroshi Nakagawa (University of Oklahoma Health Sciences Center, USA) and Prof. Pramesh Kovoor (Westmead Hospital, Australia).

Topics presented included: clinical advantages of the Stereotaxis technology and magnetic navigation vs. manual lesions. Over 80 EP professionals attended this informative and engaging event and concluded with in-depth one-on-one Q&A.

EHRA Europace June 21-24 (Milan, Italy)

This year’s EHRA Europace congress was held at the MiCo Congressi with a record high attendance of over 5,700 global visitors. Stereotaxis proudly participated in this scientific session with several activities including: an interactive booth showcasing the latest in product technology and clinical research, an educational dinner celebrating Stereotaxis’ 25th anniversary and a live case transmission from Humanitas Research Hospital (Italy). Dr. Maurizio Gasparini performed a complex left atrial procedure with the Niobe™ magnetic navigation system and commented that the Niobe system is more precise in creating an ablation line and has a high safety profile. He also spoke of his back pain and concluded that the Stereotaxis technology has enabled him to continue to perform ablations that would otherwise not have been possible.

China Atrial FibrillationSymposiumJuly 9-12 (Dalian, China)

The 13th Annual China AF Symposium took place in the beautiful coastal city of Dalian in early July. At this meeting, Dr. Gabriel Latcu (Princess Grace Hospital, Monaco) transmitted a live case presentation from Monaco into the conference center. Dr. Latcu presented a clinical procedure that was performed with the Niobe™ magnetic navigation system along with his positive experience and research on magnetic navigation. His “Hello China” greeting was warmly received by the audience and his lecture was prominently featured in the official symposium report.

European Society of Cardiology (ESC)August 29 – September 2(London, United Kingdom)

The recent ESC congress acted as host to more than 32,000 participants in London and covered all facets of cardiology ranging from

electrophysiology to interventional cardiology to public health. This year, three abstracts covering the Niobe™ magnetic navigation system were accepted and presented during the scientific session. These poster sessions included clinical research from Royal Brompton & Harefield (London, United Kingdom), ZNA Cardiovascular Centrum (Antwerp, Belgium) and National Heart Centre Singapore (Singapore).

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The Vmotion suite of automations was recently approved by the U.S. FDA and has been installed at Advocate Christ Medical Center (Chicago, IL) and Exempla St. Joseph Hospital (Denver, CO). Vmotion automations include three components that utilize the V-Sono™ ICE catheter manipulator to move an ICE catheter without direct manipulation by the physician. Physicians can select from the following automation:

• Spotlight - automatically adjusts the ultrasound catheter so that the mapping catheter is kept in its field of view

• Stored Positions - allows for positions of the ultrasound catheter to be recalled and returned to throughout the procedure

• Sweep - enables the ultrasound field of view to continuously sweep across an area of interest defined by the user

To date, fourteen procedures have been conducted by four different physicians. Enthusiasm is particularly high for the Spotlight function. By continually keeping the ablation catheter tip within the ICE viewing plane, physicians are able to continually monitor tip-to-tissue contact and further reduce their need to step on the fluoroscopy pedal.

Questions? Contact [email protected]

Vmotion Suite of Automations

Respiratory Compensation

Introducing Advanced Features

"With the stable focal contact [Niobe] provides, the latest iteration of Ablation History with Respiratory Compensation creates a more

precise representation of where lesion sets are actually being created. I am confident this further improves my ability to create

contiguous lesions prior to the onset of edema."

Stereotaxis has begun the early introduction of the latest enhancement to the Niobe™ magnetic navigation system. This new feature, “Respiratory Compensation”, further enhances Ablation History and automated targeting in the Navigant™ 4.6 software by compensating for the respiratory excursion of the ablation catheter. This is accomplished by monitoring the movements of a reference catheter over the respiratory cycle. This information is used to gather ablation history at the most accurate location and improve targeting algorithms.

without compensation with compensation

The U.S. Patent and Trademark Office recently issued U.S. Patent No. 9,111,016 to Stereotaxis entitled “Management of Live Remote Medical Display.” This patent allows for the future development of features within the Odyssey™ Information Management Solution that optimize data transmission across a network to a high-resolution display facilitating the management of medical procedures. Stereotaxis holds more than 100 issued patents within its product portfolio.

The Odyssey solution is comprised of two components: the Odyssey Vision™ and Odyssey Cinema™ systems.

The Odyssey Cinema system is a groundbreaking information management system which delivers a real-time view of live and recorded clinical procedures anytime, anywhere. Clinical procedures may be recorded in real-time and saved for future viewing. When reviewing an archived procedure, a physician can fast-forward, rewind and add bookmarks to the recording. The powerful server simultaneously connects many labs with independent access from many locations at once and utilizes exclusive video compression technology to maintain extremely high visual quality at ultra-bandwidths.

TRAINING ROOM

PHYSICIAN’S OFFICE

ODYSSEY VISION™ SYSTEM

ODYSSEY CINEMA™ SYSTEM

LIVE CASE TRANSMISSIONSCIENTIFIC SESSIONS

Dr. Peter Weiss (Intermountain Medical Center, Salt Lake City, UT) shares his recent experience,

Odyssey Cinema™ System

An EP lab houses various systems, often sourced from multiple vendors. As a result, clinical data exists in silos, is often lost and inaccessible, and case reviews lack full procedure content.

This Odyssey lab solution aggregates and integrates a vast number of clinical lab information into one large screen and a single mouse and keyboard control. This allows the physicians to focus on a consolidated view of the most relevant information during each step of the procedure in order to maximize procedure efficiency.

Odyssey Vision™ System

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Questions? Contact [email protected]

New System Installation

FirstClinicalProcedurein JapanDr. Kohei Yamashiro of Takatsuki General Hospital is the first Niobe™ ES system user in Japan. He partnered with Stereotaxis for Best Practices education prior to his first live cases, and has now used the Niobe system for more than 40 EP procedures in his practice.

"We are excited to be the first institution in Japan to offer this unique, innovative approach to treating complex cardiac arrhythmias, which continue to rise in prevalence at a rapid rate with our aging population," said Dr. Yamashiro. "The Niobe system provides greater visibility and precise control of the ablation catheter, as well as significantly increased safety, which I expect to translate into improved outcomes for my patients."

Installation of the Niobe system was completed in the first half of 2015. During this time, Dr. Yamashiro also received comprehensive training at Stereotaxis sites in the U.S.

Summer 2015 marked a career milestone for Dr. J. David Burkhardt (St. David’s Medical Center, Austin, TX) as he surpassed 1,000 EP procedures using the Niobe™ remote magnetic navigation system.

The Texas Cardiac Arrhythmia Institute at St. David’s Medical Center installed the Niobe™ system in 2009 and under the leadership of Dr. Andrea Natale, Executive Medical Director, has since adopted the magnetic navigation technology as the standard-of-care for treating patients diagnosed with ventricular tachycardia (VT). Dr. Burkhardt treats over 95% of his VT patients with the Niobe system. Beyond VT, he also uses the technology to treat congenital heart disease patients. He describes the technology and the soft magnetic catheter being able to “get to places [of the heart] you can’t with manual catheters.”

As a committed research hospital, St. David’s Medical Center is planning to release comparative data on the treatment of VT (remote magnetic navigation vs. manual) at the upcoming American Heart Association (AHA) conference in November.

The hospital held a grand opening lecture on July 3 featuring presentations by Dr. Yamashiro and Dr. Hiroshi Nakagawa, a prominent electrophysiologist, who has educated Japanese physicians and government officials on the use of the Stereotaxis technology.

Takatsuki General Hospital is located near Osaka, Japan and recently underwent a complete renovation to support the latest medical advances and provide higher quality, more integrated patient services.

Dr. J. David Burkhardt surpasses 1000+ EP procedures with Niobe™ system

In August, a new Niobe™ magnetic navigation system was installed at Sutter Medical Center (Sacramento, CA).

Physicians have commented positively on the stability of the magnetic catheter and the constant contact to the cardiac wall.

Early excitement surrounds this new installation and physicians appreciate that the technology has allowed them to reach areas of the heart otherwise unreachable by manual navigation.

Visit http://goo.gl/8e1MzX to see Dr. Burkhardt's presentation at the 2015 Heart Rhythm scientific session.

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Latest Scientific Publications

Questions? Contact [email protected]

This research study focused on the results of a bench (non‐human) study that simulated heart movement (validated phantom) to investigate RF lesion dimensions in two groups: Biosense Webster’s NAVISTAR™ THERMOCOOL™ manual catheter (MC) vs. Biosense Webster’s NAVISTAR™ RMT THERMOCOOL™ magnetic catheter with the Niobe™ magnetic navigation system (MNS).

Objective

During motion, the manual catheter slid across the surface 5.5 mm while the magnetic catheter maintained stable focal contact. This resulted in volumetrically larger lesion sizes for the Niobe™ magnetic navigation system.

Conclusion

Above figure shows the inferior approach with motion.

A statistically significantly higher lesion volume is produced by MNS (60.2 mm3) when compared to MC (42.8 mm3).

Figure 3c

Figure 6b & 6d

Figure 3d Figure 4d

Above figure shows the superior approach with motion.

A statistically significantly higher lesion volume is produced by MNS (74.1 mm3) when compared to MC (54.2 mm3).

In MC ablations with simulated motion, there is a significant delay in lesion growth and the final lesion depth is less (p<0.001).

Note larger lesions for MNS ablations (left) when compared to MC ablations (right).

Results

J Interv Card Electrophysiol. 2015 Jun 30. [Epub ahead of print]

Bhaskaran et al., University of Sydney(PMID: 26123094)

Conclusion

to MC (42.8 mm3).

Figure 6b & 6d

pto MC (54.2 mm3).

Notecom

MNS MC

Magnetic guidance versus manual control: comparison of radiofrequency lesion dimensions and evaluation of the effect of heart wall motion in a myocardial phantom

View the bench model video http://goo.gl/pTOAuH

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Latest Scientific Publications

J Interv Card Electrophysiol. 2015 Jun 30. [Epub ahead of print]

Questions? Contact [email protected]

Compare contact force (CF) ablation to manual ablation (MAN) and remote magnetic navigation (RMN) ablation for safety and efficacy in acute and long-term outcome.

A total of 239 consecutive patients undergoing VT ablation, with the use of MAN (n=112), CF (n=41) or RMN (n=86) catheters were included in this single center cohort study from January 2007 until March 2014. The median follow-up period was 25 months.

Objective

Results

Methods

Safety & Clinical Outcome of Catheter Ablation of Ventricular Arrhythmias Using Contact Force Sensing, Consecutive Case Series

Hendriks et al., Erasmus Medical Center(PMID: 26200478)

Section 1: Main Findings

The RMN group had fewer RF applications (p=0.02).

Procedure Outcomes

For structural heart disease (SHD), there were no statistically significant differences between acute success outcomes: CF (73%), MAN (78%), RMN (81%). For Non-SHD, acute success for RMN was statistically higher compared to both of the other groups: CF (68%), MAN (62%), RMN (88%). Note that the p–values above are both below p<0.05 indicating statistical significance (RMN vs. CF (20% difference) and RMN vs. MAN (26% difference)).

Acute Success

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Latest Scientific Publications - continued

Questions? Contact [email protected]

Direct quote from article: “The use of CF sensing catheters did not improve procedural outcome or safety profile in comparison to non-CF sensing ablation in this observational study of ventricular arrhythmia ablations. RMN was superior with regard to acute success, reduction of major complications and recurrence rate using an intention-to-treat analysis.”

Conclusion

CF MAN RMN p-value Comment Pa ents

-Overall Acute Success

71% 71%

86%

0.03 Favors RMN

Combines SHD and Non-SHD pa ents

-Long-term Success (All pts) 41% 43% 58% 0.07 Strong trend toward sta s cal significance favoring RMN

Safety -All Complica ons 19% 12% 6% 0.06 Strong trend toward sta s cal

significance favoring RMN -Death 1 0 0 n/a Death from refractory heart

failure a er failed VT abla on

Section 2: Additional Results

The RMN group (1.2%) had significantly fewer complications than the CF group (10%).

Major Complications

The Kaplan-Meier analysis demonstrated that the RMN group had the highest recurrence-free survivorship rate.

Survival Analysis

Niobe™ is a registered trademark of Stereotaxis, Inc. in the United States, Japan, and the European Community. Odyssey™ and Odyssey Cinema™ are registered trademarks of Stereotaxis, Inc. in the United States and the European Community. Odyssey Vision™ and V-Sono™ are trademarks of Stereotaxis, Inc. All other brand names, product names, or trademarks are the property of their respective owners.

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