MEMS application for treating cardiac rhythm disorder

We recently spoke with Eric Le Royer, CEO of Geneva-based Endosense, about how his company applied MEMS technology to the development of a new catheter to improve the procedures for treating atrial fibrillation. According to Mr. Le Royer, atrial fibrillation is today’s most prevalent cardiac rhythm disorder and is estimated to affect more than 6 million people worldwide. Of these, approximately 2.6 million cases have been treated by three types of therapy – 2.5 million with drugs, 60,000 with surgery and 70,000 with conventional catheter ablation. The catheter market for treating atrial cardiac disorder is expected to grow from $500 million today at a rate of 20% per annum and reach $1.25 billion in 2015.

MEMS Investor Journal: Please provide a short history of Endosense to introduce the company to our readers.

Eric Le Royer: Endosense was founded in Geneva, Switzerland in 2003 as a medical technology company. Our 25 employees focus on enabling the broad adoption of catheter ablation for the treatment of cardiac arrhythmias, specifically atrial fibrillation (AF). In 2005 we announced the closing of a CHF 26 million ($20 million) financing with 3i and NeoMed.

AF is the most prevalent cardiac rhythm disorder today, estimated to affect more than 6 million people worldwide. People suffering from AF experience irregular heartbeats due to abnormal electrical activity in the upper chambers of the heart. Therapies include drugs, invasive surgery and conventional catheter ablation, all of which have drawbacks. Our flagship product is the TactiCath™, the first force-sensing ablation catheter to give physicians a real-time, objective measure of contact force during the catheter ablation procedure. It effectively eliminates the drawback of conventional catheter ablation.

Through further technology development, the catheter ablation market is anticipated to grow at 20% per annum from $500 million today to reach $1.25 billion in 2015. Once it receives approvals for use in the European and US markets, the TactiCath is positioned to potentially dramatically increase the adoption of catheter ablation to double-digit percentages. The sizeable AF patient population represents a multi-billion dollar market opportunity for Endosense.

MEMS Investor Journal: Describe the TactiCath and why it is needed. That is, what does it do that makes it different from other AF therapies on the market?

Eric Le Royer: In the catheter ablation process, radio frequency waves create targeted lesions along the heart wall to eliminate the abnormal electrical activity. The problem until now is accurately measuring the force required to create the lesions. If too slight, the treatment is ineffective; if too great it may perforate the heart wall. With TactiCath, cardiologists can be assured that they are using just the right force for the right lesion creation.

Pre-clinical studies have shown that TactiCath has the potential to positively impact the safety and efficacy of catheter ablation for the treatment of AF and other cardiac arrhythmias.

MEMS Investor Journal: Describe the alternate therapies. What are their advantages and drawbacks in the context of how the TactiCath addresses drawbacks?

Eric Le Royer: First it is important to understand that AF therapy is elective as people can live with it for many years, although not comfortably.

Looking at invasive surgery, it would apply to treating AF only in conjunction with another procedure such as open-heart surgery simply because of risks of complications and long recovery times. In this case, lesions are created in the heart wall to eliminate the abnormal electrical activity. Approximately 60,000 surgical procedures have been performed with a long-term effectiveness of 80%.

The predominant therapy is through drugs, which have been used in approximately 2.5 million cases, but with a long-term effectiveness of less than 40%. Additionally, drugs can cause significant side effects.

Catheter ablation using radio frequency as currently practiced provides an effective and minimally invasive alternative. To date it has been used to treat approximately 70,000 cases with a long-term effectiveness of 60% to 90%.

Catheter ablation is accomplished by threading an ablation catheter through a vein in the patient’s groin area to the upper chambers of the heart. While outside guidance is provided using various technologies – such as fluoroscopy, 3-D mapping and ultrasound – there has been until now, as mentioned earlier, no means by which physicians can assess the level of contact force required to create the lesions.

The use of catheter ablation has been limited largely because it has the disadvantage of being complex while giving unpredictable results. The TactiCath directly addresses these issues.

MEMS Investor Journal: Referring to the previous question, what companies are competing in this market through their particular technologies or treatments? Within the AF space what is their market share?

Eric Le Royer: Major medtech companies compete in the catheter ablation market for the treatment of AF. The leader is Biosense Webster, a division of J&J with approximately 47% of the market according to 2007 MRG Market Track. Other contenders are Boston Scientific at 28%, the combined Medtronic/Cryocath at 11%, and St. Jude Medical at 6%.

MEMS Investor Journal: How do you see TactiCath’s participation in this market once CE Mark approval is obtained – and the same for the North American market when those approvals are obtained?

Eric Le Royer: The TactiCath has the potential to dramatically develop the catheter ablation market while taking a sizable portion of the current market. It is under clinical evaluation towards obtaining the CE mark in first part of 2009 and will be first commercialized in Europe. We expect US approvals in approximately three years following an extensive clinical evaluation.

MEMS Investor Journal: Do you believe your growth will depend primarily on replacing existing therapies, increased incidents of AF or both?

Eric Le Royer: The growth will be mainly driven by treating more AF patients. We do not see TactiCath as replacing invasive surgery because, as mentioned earlier, that therapy is typically used for concomitant procedures. Instead, we see our potential in replacing drug therapy and in replacing current catheter ablation therapy by simplifying the procedure and providing high assurances of treatment accuracy.

MEMS Investor Journal: What factors will be weighed in making decisions to use one therapy versus another?

Eric Le Royer: Cardiologists are often desperate to find a solution for symptomatic drug refractory patients, which comprise more than 20% of the cases. Therefore, a lot of patients are waiting for a solution. More physicians trained to do AF catheter ablation with the right tools – as exemplified by TactiCath – will increase significantly the penetration of catheter ablation.

Currently, around 20% of electro-physiologists (cardiologists specialized to treat cardiac rhythm disorders) are performing this procedure. With improved tools to perform the procedure, the growth of AF catheter ablation is going to accelerate. The scientific cardiology societies have changed their guidelines one or two years ago to consider catheter ablation as the second line therapy (after drugs) for symptomatic AF patients.

Reimbursement for the procedure, which costs approximately $8,000, is in place in most major industrialized countries such as the U.S. with an average of 60% and Europe at 30%. Studies show that catheter ablation is more cost effective than drugs because patients to not have to pay for recurring pharmaceutical treatments, which can reach as high as $3000 per year.

MEMS Investor Journal: What were some of the main challenges Endosense met in developing the product?

Eric Le Royer: Inserting a force sensor in a replaceable 2.3 mm diameter catheter without compromising the physical and therapeutic characteristics of the catheter was the main challenge. Measurements at the tip with sensitivity of one gram are conducted at 100 ms intervals and displayed on a monitor. Along with the force sensor, the catheter includes fiber optics, RF and saline solution delivery systems all assembled under a microscope in a clean room environment.

MEMS Investor Journal: What organizations are customers for the TactiCath if other than cardiac care units at hospitals, and what is your price point?

Eric Le Royer: The main customer is the electro-physiologist, the cardiologist specialized in the treatment of cardiac rhythm disorders. Catheter ablation is performed in electrophysiology labs, of which there are approximately 2,500 worldwide. Of these, half are equipped to do AF catheter ablation but only 20% of them are doing it actively because of the drawbacks cited above.
AF catheters sell between $800 and $3000. We expect to set our prices at the higher end of the range. Based on our future cost projections, this should provide us a competitive gross margin with volume.

MEMS Investor Journal: What is the feedback from preclinical testing here and in Europe?

Eric Le Royer: The feedback is excellent. We are providing a new dimension to the physicians. This new dimension can change the clinical practice and become a standard for catheter ablation. Data collected show the TactiCath has the potential to positively impact the safety and efficacy of catheter ablation for the treatment of AF and other cardiac arrhythmias.

MEMS Investor Journal: What are the challenges being faced by Endosense in terms of product improvements, manufacturing and pricing?

Eric Le Royer: Endosense is securing several technologies to increase the reliability of the sensor, improve the catheter performance and manage its cost structure. First to market with a force sensor ablation catheter, Endosense strives to maintain its leadership with future generations.

MEMS Investor Journal: What do you see as the next major development in treating AF? Where is this technology headed?

Eric Le Royer: Remote navigation and automation with the use of robotics have shown early promises. A force sensor catheter may help its acceptance.

MEMS Investor Journal: Can you share with us for publication the names of hospitals currently conducting trials?

Eric Le Royer: There are several. Asklepios Hospital St. Georg in Hamburg in Germany (Principal Investigator), University Hospital of Geneva, Princess Grace Hospital Monaco, Herzzentrum Bad Krozingen in Germany, Herzzentrum Leipzig in Germany, Hôpital Haut-Lévêque in Bordeaux, Prague University Hospital.

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Eric Le Royer is a medical device industry professional with more than 15 years of leadership experience in global marketing, sales and business management. Since joining Endosense in 2005, he has led the continued development of the company’s proprietary Touch+™ fiber optic sensor technology and its flagship product, the TactiCath™ force-sensing ablation catheter. Prior to Endosense, Le Royer spent nearly 15 years at Guidant Corp., where he held various leadership positions on three continents. His most recent roles included vice president of marketing for Europe, general manager of the U.S. carotid and peripheral business unit, and director of the cardiac rhythm management unit in Japan. Le Royer received his engineering degree (diplôme d’ingénieur) from the Ecole Supérieure d’Electricité in France and a master’s degree in electrical engineering from the University of Houston. He also earned a master’s degree in business administration from Columbia University.

Copyright 2008 MEMS Investor Journal

Comments

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This is a very informative review.

[cardiac bypass surgery]

Since the 1990s, surgeons have begun to perform "off-pump bypass surgery" - coronary artery bypass surgery without the aforementioned cardiopulmonary bypass. In these operations, the heart is beating during surgery, but is stabilized to provide an almost still work area. Some researchers believe this approach results in fewer post-operative complications (such as postperfusion syndrome) and better overall results (study results are controversial as of 2007, the surgeon's preference and hospital results still play a major role).

[cardiac failure]

Common causes of heart failure include myocardial infarction and other forms of ischemic heart disease, hypertension, valvular heart disease and cardiomyopathy. Heart failure can cause a large variety of symptoms such as shortness of breath (typically worse when lying flat, which is called orthopnea), coughing, ankle swelling and reduced exercise capacity. Heart failure is often undiagnosed due to a lack of a universally agreed definition and challenges in definitive diagnosis. Treatment commonly consists of lifestyle measures (such as decreased salt intake) and medications, and sometimes devices or even surgery.

[cardiac complication]

The first hour of a heart attack is known as the "golden hour." If you get help during that first hour, your chances of recovery are greatly improved. Yet many people hesitate to get help when they first experience symptoms. They're afraid of the embarrassment of going to the emergency room and finding that nothing is wrong. So, it is important that you know the symptoms that may indicate that a heart attack is in progress.

Many of the symptoms of heart attack can be brought on by digestive disturbances or other less serious conditions. But only sophisticated medical tests can determine for sure if you're having a heart attack. Heart attacks may vary from person to person, and from heart attack to heart attack. Women, for example, may experience "atypical' symptoms such as pain between the shoulder blades rather than crushing chest pain. This may result in them delaying seeking treatment. That is a great mistake.

[acute heart]

Although heart failure is a chronic condition, acute exacerbations are frequent and occur with serious complications; patients with heart failure and their families can help improve prognosis in acute events if they are taught to recognise the tell-tale signs of worsening condition and seek immediate medical help. "Any delayed recognition of these signs is associated with an increased rate of hospitalisation and complications, including mortality," says Professor Ferenc Follath from the University Hospital of Zurich, Switzerland.

[rare heart]

The recently recognized disease is a type of cardiomyopathy, or heart muscle disorder, linked to genetic mutations in the lysosome-associated membrane protein gene (LAMP2). Until now, the natural course of the disease was unclear.

Researchers from the Minneapolis Heart Institute Foundation studied seven people diagnosed with Danon disease when they were 7 to 17 years old. In six of them, diagnosis was made as the result of a heart murmur, family screening and findings on routine electrocardiogram tests or from such symptoms as chest pain and fainting. In one person, atrial fibrillation, an abnormal heart rhythm, led to the diagnosis.

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I just read that some arrhythmias do not cause symptoms, and are not associated with increased mortality. However, some asymptomatic arrhythmias are associated with adverse events. Examples include a higher risk of blood clotting within the heart and a higher risk of insufficient blood being transported to the heart because of weak heartbeat. Other increased risks are of embolisation and stroke, heart failure and sudden cardiac death.