Who Should Get An Mri-compatible Pacemaker?
Who Should Get An MRI-Compatible Pacemaker? The Medtronic Revo MRI SureScan pacemaker is out, and the natural question arises: who should get it? Up until now, pacemakers have not coexisted well with MRI scanners. Problems including inductive heating of the leads, spurious reprogramming, and various malfunctions have been reported. Up until now, patients getting pacemakers have been told that they could not ever get MRI scans, and thats that. Now that there is an MRI compatible pacemaker, should all new pacemaker candidates get one? Im sure Medtronic would be happy if the answer to this question is yes. The new pacemaker and leads are more expensive than their other pacemakers, and, given the ugly morass that is the U.S. Patent Office, where a company like Microsoft can patent double-clicking with a mouse, Im sure Medtronic holds a bunch of patents on MRI compatible pacemakers that will suppress any healthy competition from other companies, or at least result in hefty licensing fees that other companies will pass on to the consumer. So the cost will stay high, though I doubt this kind of pacemaker is any more difficult to make than any other pacemaker. So the question becomes: is it worth the added cost of this pacing system just to ensure that sometime in the future a patient may be able to get an MRI scan? I might add that, in addition to the added cost, the system uses larger caliber leads, and the Revo generator has an upper tracking rate of only 150 bpm, making it less attractive for use in younger patients who might be more likely to need an MRI scan over the course of their lifetime. Medtronic states on their website that 75% of pacemaker patients will have an indication for an MRI scan during the lifetime of their device. I think this statistic needs to be take Continue reading >>
Cost Of Permanent Pacemaker Implantation In India
The pacemaker is a surgically implanted device that prompts small electrical impulses to heart muscles so that normal heart rate is maintained or reinstated in cases where there is slow or erratic heart rate. Brady-arrhythmia is the commonest cause for pacemaker implantation, though the pacemaker decision is based on cause of arrhythmia, the level and the permanency of the condition, symptoms and risks to the patient. The artificial pacemaker consists of following components: A pulse generator which comprises of a thin metal box which produces the electrical impulses and a computer processor to set the rate, pattern, output and other parameters. Leads carrying electrical impulses to the heart muscles from the generator. Electrodes at the ends of leads to transmit electrical impulses to the heart muscles. There are different types of pacemakers to restore or maintain a regular heartbeat: Demand pacemakers operate when the heart's own pacemaker is slow. Rate-responsive pacemakers increase or decrease heart rate according to the body requirement like in rest or during activity. Single-chamber pacemakers: These carry impulses of either right atrium or right ventricle. A dual-chamber pacemaker: This has two leads, to the right atrium and right ventricle so that a more natural approach of the heart activity is obtained. Triple-chambered pacemaker: This has leads to the right atrium, the right ventricle, and left ventricle. It is used in case when the heart muscles are weak. Temporary pacemakers are used as a temporary solution for short term problem as during a surgery, he electrical impulses are generated outside. Permanent pacemakers are for long-term use. Pacemaker implantation procedure is done by specially trained cardiologists or electro physiologists who are experienc Continue reading >>
Medicare To Cover Implants Of Medtronic's Micra Pacemaker
Medicare will soon cover implants of Medtronics tiny new pacemaker, the Micra, when the device is implanted as part of a long-term clinical study. The device received U.S. Food and Drug Administration approval last April, to much industry fanfare. But financial analysts say its often insurance coverage decisions that determine whether a novel technology succeeds financially, and Medicare is the nations largest health insurer. Reimbursement by insurance companies has increasingly been the gating factor for a new products financial success. For Micra, the [Medicare] decision is particularly impactful since pacemakers trend more toward an elderly, i.e. Medicare, population, retired Minneapolis med-tech industry analyst Thomas Gunderson said via e-mail. Developed in Minnesota, the Micra Transcatheter Pacemaker System is less than 10 percent the size of a traditional pacemaker, allowing it be implanted directly inside the hearts right ventricle without open-chest surgery. It was designed with a slim profile so the doctor can thread it into the heart from a small puncture in a blood vessel in the groin. The Centers for Medicare and Medicaid Services (CMS) decision to cover Micra implants hinges on Medtronic using well-designed and potentially expensive studies to collect clinical evidence over a long period of time. Medicare will begin covering the devices as soon as CMS approves the studies. Although Micra pacemakers have batteries that could last eight to 12 years, no patient has had one long enough to deplete the battery. The devices can be retrieved if necessary, but Medtronic says they are designed to stay in the heart after the battery depletes. Additional devices can be placed alongside the depleted ones, if needed. Medtronic is pleased with the CMS decision to cover Continue reading >>
Cost Of A Pacemaker - Consumer Information - Costhelper
A pacemaker is a battery-operated device implanted or externally attached to the body to direct electrical impulses when needed to stimulate the heart to beat regularly and properly circulate blood. An implantable defibrillator[ 1 ] , a larger device with a pacemaker built in, is placed inside the body near the collar bone to monitor the heart rate and deliver a strong electrical shock restoring the heartbeat to normal if it has become too fast or too slow. For patients not covered by insurance, a pacemaker and heart-assist implant can cost $19,000-$96,000 or more, depending on the type of pacemaker, the location and length of the hospital stay. For example, the Healthcare Bluebook[ 2 ] estimates a total price of $19,651 for patients in the Columbus, OH, area, including placement of the pacemaker, surgery, anesthesia and a five-day hospital stay. HealthGrades.com[ 3 ] estimates an average list price of $28,348 for the implant and procedure for patients in the western United States. Wisconsin PricePoint[ 4 ] , a subsidiary of the Wisconsin Hospital Association that collects healthcare price data, estimates the average costs of a defibrillator and heart assist implant in that state are about $96,000. Pacemakers may be covered by Medicare or private health insurance. For patients with Medicare, the Dartmouth-Hitchcock Medical Center in New Hampshire estimates an out-of-pocket cost[ 5 ] of $2,604, including deductibles and coinsurance. Patients with private insurance could expect to pay[ 6 ] about $4,400. Related articles: Heart Stent , Heart Rate Monitor , Cholesterol Test , Medicare , Health Insurance Placing a pacemaker is considered minor surgery, according to the National Heart Lung and Blood Institute[ 7 ] . First, a doctor will numb the area where the pacemaker will Continue reading >>
Cost Advantage Of Dual-chamber Versus Single-chamber Cardioverter-defibrillator Implantation - Sciencedirect
Cost Advantage of Dual-Chamber Versus Single-Chamber Cardioverter-Defibrillator Implantation The purpose of this study was to determine the least expensive strategy for device selection in patients receiving implantable cardioverter-defibrillators (ICDs). Device cost for a single-chamber ICD is less than an atrioventricular (dual-chamber) ICD (AV-ICD); however, some patients without clinical need for AV-ICD at implantation might require a later upgrade, potentially offsetting the initial cost advantage of the single-chamber device. Decision analysis was used to estimate expected resource utilization costs of three alternative implantation strategies: 1) single-chamber device in all, with later upgrade to AV-ICD if needed; 2) initial implantation of an AV-ICD in all; and 3) targeted device selection on the basis of results of electrophysiologic testing (presence or absence of induced bradyarrhythmias or atrial arrhythmias). Clinical base estimates were obtained from retrospective review of all patients receiving ICDs between June 1997 and July 2001 at a single university hospital. Economic inputs were collected from national and single-center sources. In patients without other indications for electrophysiologic study (EPS), the expected per-person cost was least with the strategy of universal initial AV-ICD implantation ($36,232) compared with initial single-chamber ICD/upgrade as needed ($39,230) or EPS-guided selection ($41,130). Sensitivity analyses demonstrated that universal AV-ICD implantation remained least expensive with upgrade rates as low as 10%. At a 5% upgrade rate, AV-ICD remained cheapest if the device cost-differential narrowed to $1,568. For patients undergoing EPS for risk assessment, EP-guided selection was least expensive. The strategy of universal A Continue reading >>
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Dual-chamber Pacemakers Worth Extra Cost By Reducing Risk Of Hospitalization And Disability
More expensive pacemakers that pace the hearts upper and lower chambers are worth the extra cost because they can reduce the risk of hospitalization and disability in patients with heart disease, according to a study published in Circulation: Journal of the American Heart Association. DALLAS, Jan. 4 More expensive pacemakers that pace the hearts upper and lower chambers are worth the extra cost because they can reduce the risk of hospitalization and disability in patients with heart disease, according to a study published in Circulation: Journal of the American Heart Association. The dual-chamber devices significantly reduced the rates of atrial fibrillation and heart failure hospitalizations, which over the long term results in a highly favorable cost-effectiveness ratio, said David J. Cohen, M.D., M.Sc., an associate professor of medicine at Harvard Medical School in Boston. Atrial fibrillation is a type of irregular heartbeat associated with an increased risk of stroke and heart failure. Single-chamber or right-ventricular pacemakers pace a ventricle, one of the hearts two large, lower pumping chambers. Dual-chamber devices also pace one of the atria (the smaller, upper chambers), which is considered a more natural synchronization. Cohen, the senior author of the study, said that during the first four years after implant the dual-chamber devices had a cost-effectiveness ratio of $53,000 per quality adjusted year of life gained. In the U.S. healthcare system, cost-effectiveness ratios between $50,000 and $100,000 per quality adjusted year of life gained are generally considered to be in the gray zone of attractiveness as health care expenditures, he said. But when we used a computer simulation model to estimate lifetime costs and benefits, the dual-chamber devices we Continue reading >>
Rs 30,000: That's All For A Pacemaker
Cost of pacemakers have been slashed in government hospitals, but they remain as costly in the open market. Cost of pacemakers have been slashed in government hospitals, but they remain as costly in the open market. The health secretary passed an order on Wednesday saying that a pacemaker in a government hospital would cost Rs 30,000. But despite its best intentions, the health department is still unable to control the price of pacemakers outside its own hospitals. The same pacemakers, if procured by patients in private nursing homes, will continue to cost Rs 45,000. Earlier, the minimum price of a pacemaker in a government hospital was Rs 60,000. The state government has named two companies which have agreed to sell pacemakers at Rs 30,000. "These manufacturers were selected after tendering," said health secretary Asim Barman. He said the government decided to regularise the cost of pacemakers in its hospitals following a recent Calcutta High Court directive. The manufacturers selected by the government will be able to supply the model till August 31, after which another set of tenders will be invited from potential suppliers. Dr Abhijeet Banerjee, head of the department of cardiology, RG Kar Medical College and Hospital, said: "This is a very positive step. Poor patients often backed out of a pacemaker transplant when told about the price. Now more and more people will be able to afford it." Dr Sushila Mitra, head of the cardio-thoracic department, SSKM Hospital, however, said: "This reduced cost is of a pacemaker with three parameters of programming. The more complex variety a" a multi-programmed pacemaker a" would cost around Rs 1,20,000." Dr Mitra informed that patients with more complicated conditions would need the second kind. The government''s initiative to fi Continue reading >>
Comparing New Leadless Pacemakers: Micra Vs. Nanostim
Comparing New Leadless Pacemakers: Micra vs. Nanostim On the back of encouraging Phase III trial results, Medtronics Micra leadless pacemaker was approved by the U.S. Food and Drug Administration in April, beating St. Jude Medicals Nanostim to approval but does it have more limitations? Despite being small for pacemakers, both devices are rather large for transfemoral catheterizationthe access site for both devices. Sheaths for St. Jude MedicalsNanostim device measure 18 French or 6mm in diameter, to which Dr. Prapa Kanagaratnam of St. Marys Hospital, Imperial College, London expressed some concern. An 18-F sheath is a big sheath to put in the leg, he said to heartwire . A lot of the patients were putting these devices into are small, elderly people, said Dr. Kanagaratnam. So its still a procedure that we feel anxious about. Micra is shorter but wider than Nanostim,with sheaths measuring 27-F or 8.333mm in diameter, which could be a negative despite beingsmaller than Nanostim overall0.8cm3 compared to 1cm3. Perhaps Micras larger sheath diameter contributed to procedural times that were longer, on average, than Nanostims37 minutes compared to 28 minutes 1 though procedural times were likely affected negatively by a learning curve in both studies. Cost-effectiveness of leadless pacemakers remains to be seen. Procedural time could become an all-important factor for the expensive devices. Medtronics Micra was estimated to cost around $10,000 whereas traditional pacemakers average $2,500on the assumption that savings in surgical costs would make it cost-effective. Even slightly shorter procedural times could tip the scales in favor of one device over the other, where efficiency is the name of the game. Pricing and cost-effectiveness of the two devices could also hinge on ex Continue reading >>
Will Medtronics Tiny Leadless Pacemaker Make A Big Impact In India?
The medical device industry is driven by technological developments. A recent example is Medtronics leadless pacemaker, Micra. It earned CE approval in 2015 and has enjoyed a warm reception from electrophysiologists. Micra is one-tenth size of a traditional pacemaker and eliminates lead issueslike infection, lead dislodgement and fractureimportant and not uncommon issues that have serious effects on patients. India has tremendous potential to have a huge customer base for this product because the country has a large aging population and an increasing prevalence of cardiovascular disease. In fact, India is now among top three countries with high diabetic population and the diabetic population has risen from 11.9 million in 1980 to 64.5 million in the country . Diabetes is associated with cardiovascular disease which can require pacemaker treatment. Micra implantation does not require surgery and is implanted through a catheter. Considering Indias low number of specialist physicians, the ease of implantation would make the device even more preferable in the country. Additionally, since it is a transcatheter procedure, less lab infrastructure is needed to implant it compared to a traditional pacemaker. What are some limitations to this products uptake in India? Micra has a price premium which is anticipated to be significantly higher than a traditional pacemaker. India is a price sensitive market. Most patients are not covered by any medical insurance, which means pacemaker implantation is a mostly out-of-pocket expense. In that case, a device with its superior technological advantages faces a challenge in gaining popularity and thus capturing market share. On the other hand the recent reimbursement plans by the Indian governmentincluding revision of the reimbursement cei Continue reading >>
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Heart Pacemaker, Medtronic Pacemaker, Pacemaker Cardiac Surgery, Pacemaker Implantation
Atrial fibrillation - irregular or increased atrial heartbeat Ventricular fibrillation - irregular or increased ventricular heartbeat Heart block - delayed or interrupted electrical signals within the heart Multiple precautions are advised for individuals under consideration for pacemaker or cardioverter defibrillators, which will be discussed by your physician or cardiac specialist. In addition, your physician will take a complete physical history to determine which type of pacemaker or implantable cardioverter defibrillator will best suit your specific needs. In the United States, any type of cardiac surgery or procedure can be relatively pricey. In the U.S., pacemakers or ICDs may cost between $15,000 and $50,000, not including doctor's fees, hospitalization, lab work, and most imaging and diagnostic testing. In the U.S., the cost of a pacemaker or ICD device itself generally runs around $10,000 per unit. However, medical travelers to foreign destinations such as India may save thousands on such units as well as implantation procedures. For example, implantation of the pacemaker in India may cost roughly $1,000, although that does not include the cost of the device. The cost of a single chamber pacemaker in India runs an average of $5,400, while a double chamber device may cost $7,200, and a biventricular pacemaker may cost just over $13,000. However, these costs are all-inclusive and include doctor's fees, hospitalization, and all lab work and diagnostic testing. Research the cost of pacemakers or ICDs both in the United States and in a variety of medical tourist destinations to compare prices, services and options. Who Performs Pacemaker or ICD Implantation? Heart and vascular surgeons generally perform pacemaker and cardioverter defibrillator implantation. The pr Continue reading >>
Medtronic's Micra | The World's Smallest Pacemaker
Share on Facebook Share on Twitter Share on Linkedin Share on Google+ Share on Xing The Medtech industry is booming with the invention of its revolutionary health care products. One such product is pacemaker that is used in patients with irregular heartbeats. Arrhythmias and bradycardia patients are hugely benefited with this product as these products are reliable regarding irregular heart beat issues. Medtronic is an Irish company famous for its world-class health technology, and solutions like Micra, the worlds smallest pacemaker. This pacemaker is less invasive as it is placed directly into the heart, thus the chances of chest incision, scar or burn have significantly come to zero. Micra is 93% smaller when compared to other conventional pacemakers. Its size is similar to the scale of any large vitamin capsule. Dr. Bruce Lindsay, who is the senior most doctors at the Cleveland Clinics Heart and Vascular Institute and section head of Cardiac Electrophysiology and Pacing department, stated that the medical institutes across the globe, including Cleveland Clinic are being pressured to keep the costs down for such devices. Key applications of Micra: Worlds smallest pacemaker With Micra, various health care professionals get the opportunity to study bradycardia and Arrhythmias disease. Medtronic helps such individuals in organizing educational workshops, where the needs of each group are catered. This includes: Electrophysiology and Cardiology Associates. These professionals can also take help from Micra TPSTMAcademy ,where they can get support and further education training related to Micra Transcatheter Pacing System(TPS). The worlds smallest Pacemaker is gaining popularity due to its incredible features: MRI Sure Scan features lets you scan by using 1.5T or 3T full bo Continue reading >>
New Wave Of Mri-safe Pacemakers Set To Ship To Hospitals
New wave of MRI-safe pacemakers set to ship to hospitals This week Medtronic will begin shipping to hospitals in the United States the first pacemaker approved by the FDA as safe for most MRI scans. For consumers, it is a significant step in what is expected to be a wave of new MRI-compatible implanted cardiac devices. But this is an example of one technology chasing another and the one being chased, the MRI scanner, is changing and is a step ahead of the new line of pacemakers. The pacemaker approved for U.S. distribution is Medtronic's first-generation pacemaker with certain limitations, while its second-generation MRI-compatible pacemaker is already in use in Europe where approval for medical devices is not as demanding as it is in the U.S. So lets check out what this is all about -- what it means now for current and future heart patients and where it may be headed. We are all born with a natural pacemaker that directs our heart to beat 60 to 100 times a minute at rest. The pacemaker is a little mass of muscle fibers the size and shape of an almond known medically as the sinoatrial node located in the right atrium, one of four chambers of the heart. The natural pacemaker can last a lifetime. Or it can become defective. And even if it keeps working normally, some point may not function well along the electrical pathway from the pacemaker to the hearts ventricles which contract to force blood out to the body. Millions of people in the world whose hearts beat too fast, too slow, or out of sync because their own pacemaker is not able to do the job right, follow their doctors recommendation to get an artificial pacemaker connected to their heart to direct its beating. The battery-run pacemaker in a titanium or titanium alloy case the size of a small cell phone, (why cant Continue reading >>
Heart Defibrillator - Medtronic - - The New York Times
Business Day |Patients Wonder Whether to Replace a Wire That Might Fail Dr. Christopher J. Magovern, right, at Morristown Memorial Hospital in New Jersey during a procedure Tuesday to replace a patients defibrillator and the wire that connects it to the heart. Credit Fred R. Conrad/The New York Times MORRISTOWN, N.J. For one heart patient, there will be no more agonizing over whether the implanted device meant to save his life might kill him instead. On Tuesday, two months after Medtronic warned doctors and nearly a quarter-million patients that a wire, or lead, connecting their electronic defibrillators to their hearts might break, the 48-year-old patient had the lead and defibrillator removed and replaced. It required a painstaking 90-minute operation here at Morristown Memorial Hospital. But thousands of other patients with failing hearts remain trapped in doubt. Their defibrillators are meant to deliver electric shocks to restore normal rhythms if their hearts start beating chaotically. Should they have the potentially faulty wire, or lead, removed or leave it in place and hope it does not fail? And if they do have it extracted, how will they pay for it? Medtronic is limiting its contribution to only a replacement lead and $800 toward each procedure, which can cost $12,500 or more. So far insurers are deciding whether to cover the replacement operation on a case-by-case basis, unless the lead has already fractured. The lead, called the Fidelis, is a spaghetti-thin plastic tube enclosing electrical wires and sensors. The risks of the patients operation, besides the possibility for infection, included potential perforation of his heart and the veins in his chest. There was also a slight danger of damaging the heart valve through which the lead had been threaded in 20 Continue reading >>
How Much Does The Procedure Cost?
Procedure costs depend on your physician and medical facility. Get in touch with them for cost information. Ask The ICD is a candid intro to living with an Implantable Cardioverter Defibrillator. AskTheICD.com has been recognized by the Heart Rhythm Society (HRS) as a quality educational tool. HRS is a leading resource on cardiac pacing and electrophysiology, representing medical, allied health and science professionals from more than 70 countries who specialize in cardiac rhythm disorders. Have a better conversation with your doctor. Just rate the following statements, then share the results with your care team at your next appointment. In the meantime, we can customize the site just for you. The ICD being a well-studied treatment option. The ICD being a well-studied treatment option. My faith or beliefs about the ICD being the right choice for me. My faith or beliefs about the ICD being the right choice for me. My spouse or family being comforted with my decision. My spouse or family being comforted with my decision. Becoming depressed after getting the ICD. Becoming depressed after getting the ICD. Becoming anxious or stressed after getting the ICD. Becoming anxious or stressed after getting the ICD. Getting shocked when around other people. Getting shocked when around other people. Not wanting other people to see my scar or ask me about my condition. Not wanting other people to see my scar or ask me about my condition. I would like to receive additional educational information, including various ICD topics, popular questions, and new questions. At any time, I may choose to stop receiving this information. Medtronic respects the confidentiality of personal information. We assure you we will not share your personal information, except as otherwise noted in our privac Continue reading >>
Global Healthcare: Medtronic's Micra Pacemaker: Game-changer, Or Business As Usual?
much of the engineering for this device has likely occurred across international borders, the Indian market and Medtronic's long-standing presence there was a big part of the company's motivation to develop this technology. In a 2010 TEDMED talk Dr. Oesterle, SVP for Medicine and Technology at Medtronic, explained that, "Right now, in the United States, for our population, we have somewhere in the region of 3,000 cardiologists who are trained in implanting pacemakers." By contrast, there are only about 1,000 implanters in India , for a population of more than one billion. By providing a technology that aligns better with the skill sets of more physicians, pacemaker technology can be delivered to more patients. That's good business for Medtronic. The benefits of the Medtronic Micra TPS include cosmetic invisibility, implantation directly into the heart, minimally invasive and easier implantation procedure, and a lead-less form factor. The device's battery life is estimated to be nearly 10 years and, once positioned, it can be easily repositioned and retrieved if necessary. The device was awarded the CE Mark in Europe after initial findings from Medtronic's global clinical trial were positive. Could Medtronic's Micra TPS Succeed in The U.S.? Medtronic could go one of two marketing routes with this device. On the one hand, they could market it disruptively as a pacemaker that performs less well on some dimensions (it's only indicated for single valve right atrial fibrillation representing about 10% of those who need a pacemaker in the U.S. per year), but better on others (less invasive, less risk of lead fractures and infections, and easier to implant), and costing less than incumbent models in the hopes of expanding the market size by targeting the needs of those who've Continue reading >>