Stereotaxis Announces European Adoption Milestone and Health Canada Market Clearance for Vdrive™ System
Stereotaxis, Inc. announced that its Vdrive™ Robotic Navigation System, which provides physicians the ability to remotely manipulate traditionally non-robotic catheters, is growing in popularity and is expected to surpass 500 clinical procedures in Europe in February. The company also announced it has received regulatory clearance from Health Canada to commercially market the device in Canada.
Since the initial product release in Europe in 2011, the Vdrive system has been installed in nine centers, with units scheduled to be installed in additional centers during the first quarter of 2012. The initial nine centers have performed 473 clinical cases with approximately 80% being completed in the left atrium of the heart.
“Numerous cases have been performed with the Vdrive system and clinical feedback continues to be very positive,” said Michael P. Kaminski, President and CEO of Stereotaxis. “With the Health Canada market clearance for the Vdrive system, and our planned new Vdrive installations in Europe and Canada this year, we are well-positioned to drive the growth and further adoption of this exciting technology in electrophysiology labs in these important markets.”
In a fully remote procedure environment, the Vdrive system increases the clinical techniques available to the physician and reduces the need to re-enter the sterile field to adjust devices. Initial clinical data from European physicians demonstrates that this simplification saves 30 minutes1 or more in robotic procedures, depending on the individual clinical technique. Furthermore, the addition of robotic diagnostic catheter manipulation is another step in Stereotaxis’ vision to improve device control. Stereotaxis’ broad Epoch™ solutions portfolio also includes precise magnetic control of ablation catheters with Niobe® ES and integrated display and control of multiple lab technologies with the Odyssey™ Clinical Information Management System.
The design of the Vdrive system allows the robotic hardware to adapt to different clinical techniques depending on the disposable adaptor that is attached to the arm:
- V-Loop™ circular catheter manipulator allows control of circular diagnostic catheters, primarily in left atrial procedures.
- V-CAS™ catheter advancement system allows advancement and retraction of the magnetic catheter as well as robotic manipulation of catheter introducer sheaths that are already in use during the procedure.
- V-CAS Deflect™ catheter advancement system is a more advanced device that includes an integrated robotic deflectable sheath.
Initial positive results from multiple physician users confirmed the significant clinical value delivered by the Vdrive system related to procedure efficiency:
- Dr. Georg Noelker of the Herz- und Diabeteszentrum NRW in Bad Oeynhausen, Germany commented on the V-Loop system: “We have adopted Vdrive for navigating the circular mapping catheter for all of our left atrial procedures. Our initial experience with Vdrive has shown that we can reduce our left atrial procedures times by approximately 30%, and can further reduce our fluoroscopy times by an additional 14% over our previous times with magnetic navigation alone.”
- Dr. Xu Chen of the Rigshospitalet in Copenhagen commented on the V-CAS system: “The addition of robotic sheath control to a magnetic procedure allows me to efficiently access even challenging areas of the heart chambers and focus on patient therapy instead of catheter control. The Vdrive control was intuitive and did not take long to implement as a part of my procedure. In difficult cases the Vdrive control even reduced my total procedure time.”
- Dr. Petr Neuzil of Homolce Hospital in Prague shared his perspective on the V-CAS Deflect system: “The advancements in the Vdrive technology use the best of previous magnetic and robotic systems to provide a new level of catheter control, which is expected to improve outcomes in ablation procedures.”
The regulatory milestone in Canada covers both the V-Loop circular catheter manipulator and the V-CAS catheter advancement system with sheath manipulator. The company’s 510(k) submission for the V-Loop circular catheter manipulator is under review by the U.S. Food and Drug Administration.
1Stereotaxis data on file
Stereotaxis designs, manufactures and markets an advanced cardiology instrument control system for use in a hospital’s interventional surgical suite to enhance the treatment of coronary artery disease and arrhythmias. The Niobe® Remote Magnetic Navigation System is designed to enable physicians to complete more complex interventional procedures by providing image-guided delivery of catheters and guidewires through the blood vessels and chambers of the heart to treatment sites. This is achieved using computer-controlled, externally applied magnetic fields that govern the motion of the working tip of the catheter or guidewire, resulting in improved navigation and reduced x-ray exposure.
Stereotaxis’ Odyssey™ portfolio of products provides an innovative enterprise solution for integrating, recording and networking interventional lab information within hospitals and around the world. Odyssey™ Vision integrates data for magnetic and standard interventional labs, enhancing the physician workflow through a consolidated display of multiple systems and eliminating the challenge of interacting simultaneously with many separate diagnostic systems. The Odyssey Cinema™ Studio then captures a complete record of synchronized procedure data that can be viewed live or from a comprehensive archive of cases performed. Odyssey™ solution then enables hospitals to efficiently share live and recorded clinical data anywhere around the world to attract patients and promote collaboration.
The core components of the Stereotaxis systems have received regulatory clearance in the U.S., Europe, Canada and elsewhere. For more information, please visit www.stereotaxis.com and www.odysseyexperience.com.
Medical Device Training Company Launches “The iPrepMD: Learn and Earn for Heart Health” Campaign
PrepMD, a leading post graduate training and placement service in the medical device field, in honor of the American Heart Association’s Heart Month announced “The iPrepMD: Learn and Earn for Heart Health” Campaign.
Throughout the months of February and March, PrepMD will donate 10% of the signup fees from people who initiate a new subscription to iPrepMD, its new web-based learning tool for the cardiology and electrophysiology device professional. Located at www.iprepmd.com, iPrepMD’s online curriculum is currently organized into 12 separate courses comprised of over 60 classes and greater than 50 hours of learning content geared toward the cardiology and electrophysiology professional.
The current course listing includes:
- The IBHRE Examinees Overview of Core Con.cepts& Fundamentals
- Test your Practical Understanding of Device Therapy
- Cardiovascular Foundations for Understanding Device Therapy
- Fundamentals of ECGs and Rhythm Analysis
- Fundamentals of Cardiac Pacing 101 – Terms and Concepts
- Fundamentals of Cardiac Pacing 102 - Device Operations
- Clinical Foundations for ICD Therapies
- Intermediate Level Cardiac Pacing Technologies
- Understanding the Pacemaker Implant
- ICD Technology - Sensing and Detection
- Cardiac Rhythm Management for the Heart Failure Patient
- Non Rhythm Related Cardiovascular Disease
“Giving back is part of PrepMD’s young legacy,” says PrepMD cofounder, Bob Mattioli. “It started with our first class who donated a much needed automatic external defibrillator to the Massachusetts Special Olympics, and has since continued in the form of service projects with subsequent classes. We see “The iPrepMD: Learn and Earn for Heart Health” Campaign as a natural extension of that spirit. “
The iPrepMD tool uses a unique blend of side-by-side display of presenter and content combined with online knowledge checks and testing to reinforce the learning experience of the iPrepMD student.
“One of our most popular offerings is the online program to help individuals who are preparing for the International Board of Heart Rhythm Examiner’s (IBHRE®) annual certification exam,” said Tom Kenny, Director of Education at PrepMD and author of the Nuts and Bolts series of books on cardiac pacing. “We have taken our onsite prep course and made it available to our online audience as well as added specific material in the form of quizzes and tests to help individuals in their studying efforts.”
“While there is no formally endorsed unaffiliated review program for the IBHRE® Exam, we can think of no one better to help direct cardiology professionals in their efforts than Tom Kenny,” says Matt O’Neal, co-founder of PrepMD, LLC. “Tom probably has more device training experience than almost anyone else in the industry. As former Vice President of Academic Affairs with St. Jude Medical, Tom has extensive experience in designing review programs and training curriculum.”
The iPrep web application allows individuals who are interested in expanding their training and knowledge around cardiac rhythm management and EP devices to take control of their own learning experience wherever and whenever they want. It uses PrepMD’s proprietary web-based platform to deliver content to any desktop or mobile device, including the iPhone and iPad.
Individuals who are interested in participating in the “The iPrepMD: Learn and Earn for Heart Health” Campaign can do so by signing up for their iPrepMD subscription at www.iprepmd.com.
PrepMD LLC (www.prepmd.org) is a post graduate training and placement service focused on delivering curriculum and educational support, specifically designed to prepare students for furthering careers in the medical device and healthcare industries. Founded by former professionals in the medical device field with more than 60 years total experience, PrepMD enrolls qualified applicants into a six-month program that gives them the training and skills required for high-paying jobs with medical device manufacturers. PrepMD also serves as a career counseling and placement program for its students and graduates. Currently, PrepMD dedicates its educational resources to a course of study addressing the Cardiac Rhythm Management and Cardiac Electrophysiology sectors of the healthcare industry. This course of study is conducted within a state-of-the-art training facility in Braintree, MA, and within observational sessions conducted among major medical centers throughout the Boston area.
Medtronic Announces First Patient Enrollment in Clinical Trial Assessing Guideline-Based Heart Failure Management in Primary Care Setting
Medtronic, Inc. announced the initiation and first patient enrollment in a clinical study that will evaluate gaps in the implementation of evidence-based treatment guidelines among chronic heart failure patients post-hospital discharge. The IMPROVE HF Bridge Study will analyze approximately 120 patients from four different centers in the United States for a period of six months following their initial hospital stay. Patients will be cared for in the outpatient setting by either a primary care physician alone, or by both a heart failure specialist and primary care physician throughout the study.
“With primary care physicians managing the ongoing follow-up and treatment of heart failure patients once they are discharged from the hospital, this study will provide new insight on what is happening from a treatment perspective once this care is transferred,” said Mihai Gheorghiade, MD, principal investigator and professor of medicine and surgery, Feinberg School of Medicine at Northwestern University, Chicago. “It is our hope that through ongoing collaboration between cardiologists and primary care physicians, we can increase adherence to treatment guidelines and ultimately enhance the quality of care and reduce hospital readmission rates among heart failure patients.”
The prospective, randomized study will also explore the feasibility of implementing Class I, Level A guideline recommendations set forth by the American College of Cardiology and American Heart Association. These include drug therapy (ACE inhibitors, beta-blockers), device therapy (implantable cardiac defibrillators, cardiac resynchronization therapy), heart failure education and anticoagulation for atrial fibrillation. Findings from this study will inform whether a larger trial to bridge the gap between guideline recommendations and actual practice will be initiated.
Each year more than 1 million patients are admitted to the hospital due to heart failure,1 and many of these patients are readmitted within 30 days due to the complex nature of managing their disease.2 While numerous evidence-based, life-prolonging drug and device therapies have been developed and are now widely available to reduce morbidity and mortality and improve quality of life for heart failure patients, these innovative therapies continue to be underutilized in both the inpatient and outpatient settings.3 For instance, cardiac resynchronization therapy is broadly underused in indicated patients despite a growing body of clinical evidence showing its benefits in reducing heart failure hospitalization and death.4 IMPROVE HF, the first-of-its-kind, prospective study involving approximately 35,000 heart failure patients from 167 U.S. cardiology practices, was designed to quantify and improve quality of care for heart failure patients by promoting the use of these evidence-based, guideline-recommended therapies.
“The commencement of the IMPROVE HF Bridge Study underscores our commitment to ensuring that all heart failure patients receive the best possible care through clinically-validated treatment options based on the individual’s specific disease-state,” said Pat Mackin, president of the Cardiac Rhythm Disease Management business and senior vice president at Medtronic.
About the IMPROVE HF Bridge Study
Heart failure patients in the study will be randomized post-hospital discharge to standard of care by a primary care physician (observational arm) or care directed by a heart failure specialist (assessment arm). The heart failure specialist will perform a comprehensive assessment of patients in the assessment arm within one week of discharge, which will include a health care utilization review and a full physical exam, and may also include specific diagnostic testing as determined by the study investigators. While heart failure specialists will not manage patients directly, they will collaborate with primary care physicians after the one-week visit is complete to make recommendations for care, including medication needs and potential device therapy indications.
Patients in the assessment arm will be followed by the heart failure specialist at 30 days, three months and six months for re-evaluation. The enrollment period is expected to take approximately 15 months from first enrollment, with total study duration of approximately 22 months.
In collaboration with leading clinicians, researchers and scientists worldwide, Medtronic offers the broadest range of innovative medical technology for the interventional and surgical treatment of cardiovascular disease and cardiac arrhythmias.
1 Centers for Disease Control and Prevention [CDC], 2006.
2 Jencks S, et al. Rehospitalizations among patients in the Medicare fee-for-service program. N Engl J Med 2009;360:1418-1428.
3 Fonarow GC. The role of in-hospital initiation of cardioprotective therapies to improve treatment rates and clinical outcomes. Rev Cardiovasc Med 2002;3:S2-S10.
4 Anand I, et al. Cardiac resynchronization therapy reduces the risk of hospitalizations in patients with advanced heart failure. Circulation 2009;119:969-977.
CardioComm Solutions Enters into the Mobile Cardiac Telemetry Arrhythmia Monitoring Software and Service Market for Cardiac Patients
CardioComm Solutions, Inc. and TZ Medical, Inc. entered into a device integration and distribution agreement for the Mobile Cardiac Telemetry (MCT) electrocardiographic (ECG) and arrhythmia management market. Under this agreement, CardioComm Solutions will integrate TZM’s new Aera CT™ MCT monitor into their proprietary GEMS™ software. The GEMS™ MCT offering will be called GEMS Aera CT and it will be an extension of CardioComm Solution’s popular GEMS™ Air (Global ECG Management System) solution.
“GEMS Aera CT will provide an efficient and cost-effective alternative for real-time, continuously-attended ambulatory cardiac monitoring for cardiac patients by combining the Internet, the Aera CT’s wireless (cellular) communication, leading-edge heart monitoring technology and CardioComm Solution’s GEMS™ based software. In doing so, it will provide constant detection, recording, transmission and analysis of cardiac rhythm dysfunctions while the patient is fully mobile,” states John Lubisich, TZM President.
Etienne Grima, CEO of CardioComm Solutions, stated, “Few companies have been able to address the need for a more beneficial mobile arrhythmia monitoring tool. The majority are large IDTFs that produce their own proprietary MCT device which was restricted for use within their own customer base. TZM has engineered the first FDA-cleared OEM MCT device which, with our GEMS software, will enable small and large IDTF and medical call centers to now enter the MCT market, a market which represents a significant revenue-generating opportunity. The MCT market is USA specific, where CMS-approved reimbursement for this diagnostic test is particularly favorable at $754.”
Bob Doerr, project manager for TZM, added, “There are more than 4 million people in the U.S. alone receiving care for recurring arrhythmias. Between 2000 and 2030, the number of people over the age of 65 will double, meaning there will be a sharp rise in the need for remediation of cardiovascular disease and associated heart ailments. The need for MCT monitoring will increase substantially, and we feel TZM is positioned well to contribute to meeting those demands. Furthermore, together with the HeartCheck™ devices, this development extends our prescription line of products and will add to our credibility in both disease management and consumer markets.”
“Outside the USA, especially in Europe and Big Emerging Markets (BEM), the wireless non-MCT configuration option of the Aera CT™ is gaining a lot of interest. Anticipated demand for the wireless MCT and non-MCT solution is great, and with the anticipation of a Windows 7 and forward compatible GEMS™ 4.0 release in 2012, this will provide for easier expansion into the ECG monitoring services market globally. Furthermore, together with the HeartCheck™ devices, this development extends our prescription line of products and will add to our credibility in both disease management and consumer markets,” Grima continued.
The deal involves CardioComm Solutions becoming a global distributor of the Aera CT™ device with exclusivity in Canada. TZM will be able to sell the GEMS Area CT software when bundled with sales of their Aera CT™ device. The first release of GEMS Aera CT will be targeting IDTF and health care facilities such as hospitals and medical clinics that already use CardioComm Solution’s GEMS™ software. The second target will be those facilities that cannot perform MCT services currently due to the lack of a commercially available MCT solution with a well-developed software back end as well as the overseas ECG services markets.
CardioComm Solutions also announced Wade Barnes has been named as the company’s Chief Technology Officer. “This will be an exciting and eventful year, and I look forward to the opportunity to guide the development of our innovative lines of products and services including the HeartCheck™ ECG Monitor and the GEMS Aera CT, both of which were first unveiled last year at Medica and our recent OTC cleared HeartCheck™ PEN. These products promise to bring patients and physicians closer together by enabling near real time, longer term, cardiac monitoring, and by placing the care provider in more direct contact with the patient.”
About CardioComm Solutions, Inc.
CardioComm’s patented and proprietary technology is used in products for recording, viewing, analyzing and storing electrocardiograms for diagnosis and management of cardiac patients. Products are sold worldwide through a combination of an external distribution network and a North American-based sales team. The company has earned the ISO 13485 certification, is HPB approved, HIPAA compliant, and has received FDA market clearance for its software devices. CardioComm Solutions, Inc. is headquartered in Toronto, Canada, with offices in Victoria, B.C.
About TZ Medical
TZ Medical’s corporate headquarters are located in Portland, Oregon, with sales and support functions spread out across the USA. TZ Medical is also part of Premier Inc., a hospital performance improvement alliance with over 1,700 participating not-for-profit hospitals and health systems serving communities nationwide. Their products and solutions can be found in hospitals, critical-care clinics and medical offices around the world.
Sorin Group Launches a New Complete Portfolio of Pacing, Defibrillation, and Left Ventricular Leads
Sorin Group announced CE Mark approval and commercial launch for a comprehensive new range of pacing, defibrillation and left ventricular leads. Designed for safety and long-term reliability, TILDA pacing leads, VIGILA defibrillation leads and CELERITY left ventricular lead families1 offer multiple implant options to accommodate patients’ needs and physicians’ preferences.
While all families benefit from flexible silicone lead body, steroid-eluting tips that reduce inflammation and iridium fractal coated electrodes with proven electrical performance,2 each lead family presents its own additional features:
- Flexible from the lead connector to the distal tip, TILDA pacing leads are designed to give physicians the instant sensation of familiarity at implant along with predictable outcomes.
- VIGILA defibrillation leads feature a symmetrical lead body and thick outer insulation. Convex shock coils embedded in silicone insulation are engineered to minimize tissue in-growth.
- Intended to improve control and handling, CELERITY left ventricular leads have a flexible co-radial body. The three pre-shaped fixation alternatives are designed to facilitate access and ensure stability in targeted pacing sites regardless of patients’ challenging coronary venous anatomies.
TILDA, VIGILA and CELERITY leads’ lasting performance and quality, combined with Sorin Group’s unique algorithms, provide reliable and individualized therapies for patients.2
“These leads are great additions to the current Sorin Group portfolios,” said Dr. David Le Froy, Consultant Cardiologist, Hammersmith Hospital, Imperial College Healthcare Trust, London, UK. “All aspects of the VIGILA, TILDA and CELERITY leads are carefully designed to enhance ease of use and handling without compromising electrical performance and safety,”1 he added. “With these new options, more patients will benefit from Sorin’s unique therapies such as SafeR™, PARAD+™ BTO™, and SonR®, some of the most efficient algorithms on the market today.”
“Instilling greater clinical confidence by delivering high performance, reliability and value to our customers is at the core of everything we do,” commented Stefano Di Lullo, Sorin Group, President of the CRM Business Unit. “This comprehensive lead portfolio complements our state-of-the-art implantable devices perfectly and will offer significant clinical benefits to each individual patient.”
About Sorin Group
Sorin Group (www.sorin.com) is a global, medical device company and a leader in the treatment of cardiovascular diseases. The company develops, manufactures, and markets medical technologies for cardiac surgery and for the treatment of cardiac rhythm disorders. With 3,700 employees worldwide, Sorin Group focuses on three major therapeutic areas: cardiopulmonary bypass (extracorporeal circulation and autotransfusion systems), cardiac rhythm management, and heart valve repair and replacement. Every year, over one million patients are treated with Sorin Group devices in more than 80 countries.
1 All three families are not available for sales or distribution in the USA
2 Sorin Group, data on file
Impulse Dynamics Coordinates Cardiac Contractility Modulation Certification Training Program
According to Impulse Dynamics, a growing number of cardiologists are employing Cardiac Contractility Modulation (CCM) to bolster their therapeutic armamentarium for patients with chronic heart failure. CCM leads to a long-term increase of cardiac contractility. At a meeting in Berlin, expert speakers addressed three of the underlying reasons for this development: (1) For large patient populations, CCM therapy is currently the only available device-based treatment alternative to pharmacologic management, (2) recent clinical results are consistently favorable, and (3) the benefits are clearly corroborated by a completed clinical study as well as by additional trials in progress.
Approximately 35 cardiologists actively implanting CCM devices in Germany accepted the invitation to attend the CCM Certification Training Program for the Optimizer III system on January 13 and 14, the first such event in 2012. The participants concur with their colleagues at close to 60 heart centers in Germany that CCM offers significant therapeutic advances for the growing number of patients with advanced symptomatic heart failure and normal QRS duration. Experience shows that, while those patients are not candidates for the more common cardiac resynchronization therapy (CRT), CCM clearly improves their quality of life and increases their exercise tolerance in comparison to medical management alone.
Dr. Christian Butter, a pioneer and well-known expert in the field of CCM therapy, hosted the event. He stated in his introductory talk about the mechanism of action behind CCM therapy: “The heart muscle is stimulated during the refractory period, a specific phase of the electrical cardiac cycle. Stimulation instantly improves myocardial calcium metabolism, thereby markedly increasing cardiac contractility without a concomitant increase of myocardial oxygen consumption. Over time, the fetal gene program of the myocardium reveres to the normal adult one. These changes are eventually capable of stopping or even reversing detrimental left ventricular remodeling processes.”
In addition to its direct effect, this type of treatment provides additional benefits to patients: Since implantation of the Optimizer III impulse generator is a minimally invasive procedure, the surgical risk is comparatively low. Other than devices such as pacemakers, implantable cardioverter defibrillators (ICD), and CRT systems, which require surgical battery replacement, CCM therapy offers the added advantage that this invasive procedure is not needed for many years: patients recharge the battery — an integral part of the impulse generator — quite easily at home.
While in Germany alone, the number of implanted Optimizer systems is now approaching 1,000, more and more new study results underline the efficacy and safety of CCM. The internationally renowned expert and principal investigator of several heart failure studies, Prof. Dr. W. T. Abraham from the Heart and Vascular Center at Ohio State University, explained in Berlin: “Cardiac contractility modulation has been studied in three randomized controlled trials. CCM is safe and shows in patients with narrow QRS complex results comparable to those of CRT therapy in wide QRS complex, and thereby significantly improves the quality of life and exercise tolerance of these patients. Outstanding results were seen in patients with baseline left ventricular ejection fraction of more than 35%, as well as in those with lower ejection fractions.” These results are particularly remarkable because until now, CCM had been primarily used in patients with severely impaired left ventricular function, i.e., an EF below 35%. Even patients with an EF clearly lower that 30% report significant and durable improvements of their exercise tolerance not attainable by other therapies.
One of the patients attending the program in Berlin, who over the years had undergone seven pacemaker implantations and one ICD implantation to stabilize his condition, remarked on the difference between living a full life and bare survival: “Only after I had the Optimizer implanted, I actually began to feel noticeably better,” he explained. The quality of life improvement was also underlined by another patient, whose mobility had been severely limited due to his heart failure and who, thanks to CCM, “can finally waltz again.”
About Impulse Dynamics
Impulse Dynamics is a medical device company dedicated to offering innovative solutions for treatment of chronic heart failure. The Optimizer III with CCM therapy is CE marked and is available in select excellence centers across Europe and Asia.