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 >>
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 >>
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 >>
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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 >>
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 >>
Medtronic Single & Dual Chamber Pacemakers
Medtronic Single & Dual Chamber Pacemakers Medtronic Single & Dual Chamber Pacemakers Delivery Location:New Delhi And Surrounding Areas This single chamber temporary pacemaker is applicable when such pacing modes are indicated for therapeutic, prophylactic, or diagnostic purposes: Rapid atrial pacing to manage atrial flutter Safety awareness ranges to alert clinician to areas of caution Reversible battery polarity for quick battery changes Safe patient cable system for patient safety The dual chamber model can be used where short-term demand (synchronous) or asynchronous pacing is indicated for therapeutic, prophylactic, or diagnostic purposes: Just 3 dials provide simple and effective dual chamber temporary pacing Changing the pacing rate automatically adjusts other dual chamber temporary pacing parameters Ventricular output to 25 mA for high stimulation thresholds Rapid atrial pacing rate up to 800 ppm for managing atrial tachyarrhythmias Advent Medical Devices was established In 2005. Our association with large hospital, medical fraternity, corporate houses opinion leaders in the government as well as trade and commercial bodies in India and Abroad has given us a unique knowledge of the fast progressing economic scenario of developing South East Asian countries with specific focus on the healthcare segment including preventive healthcare. Successfully leveraged on the drivers of growth with our knowledge and commitment to grow the business. We are governed by highest ideals of corporate governance. Over decades we have successfully worked with various International and try to bridge the gap between domestic and International know how of the product line. We have been successful in letting the medical fraternity embrace the new technologies. Since the inception of th Continue reading >>
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Cost May Be A Hurdle For The First Fda-approved Leadless Pacemaker
Cost may be a hurdle for the first FDA-approved leadless pacemaker The approval of a pacemaker that works without the use of wired leads is being heralded as a major win for patients at risk of complications from traditional devices. But cost and potential limitations on how it performs could hinder widespread use of Medtronic's Micra Transcatheter Pacing System. The 1-inch device, the world's smallest pacemaker, is implanted directly onto the heart's right ventricle chamber and uses prongs that generate electrical impulses to regulate heart beats in the same fashion as traditional pacemakers. Conventional pacemakers require electrodes to be inserted through a large vein into chambers of the heart. The device is implanted just under the skin below the collarbone. Though complications of this implantation are uncommon, the electrodes can break, become dislodged or become infected, requiring subsequent procedures. Micra inserts through a vein in the patient's groin and then affixes to the heart. A clinical trial involving 719 patients implanted with Micra found 98% had adequate heart pacing six months after implantation with complications occurring in less than 7% of trial participants, according to the Food and Drug Administration. Many professionals see Micra as a major advancement in technology that has remained largely unchanged for decades. But the device carries a big price tag. Medtronic has not disclosed the device's actual cost. But the estimates of about $10,000 compared with conventional pacemakers that average about $2,500 is raising some eyebrows, especially among hospital officials whose facilities receive lump sum Medicare payments for such procedures. Dr. Bruce Lindsay, section head for Cardiac Electrophysiology and Pacing at the Cleveland Clinic's Heart Continue reading >>
Getting A Pacemaker - Bradycardia | Medtronic
The procedure to implant a pacemaker does not require open heart surgery, and most people go home within 24 hours. Before the surgery, medication may be given to make you sleepy and comfortable. Generally, the procedure is performed under local anesthesia. How is a traditional pacemaker system implanted? A small incision, approximately 5 cm long is made in the upper chest. A lead (thin insulated wire, like spaghetti noodle) is guided through the vein into the heart. Your doctor connects the lead to the pacemaker and programs the device. The pacemaker is then inserted beneath the skin. Your doctor tests the pacemaker to ensure it is working properly. How is the Micra transcatheter pacing system implanted? Your doctor will insert a straw-like catheter system into a vein, typically near the upper thigh area of your leg. The catheter system moves the Micra into the right ventricle of the heart. The Micra TPS is placed against the heart wall and secured with flexible tines (see image at the far right below). Your doctor tests the Micra to ensure it is working properly. Continue reading >>
Worlds Tiniest Pacemaker Debuts: About 1 Inch Long
(1 of ) Medtronic in 2017 releases Micra TPS, a tiny, leadless pacemaker. (Medtronic) (2 of ) Medtronic's new Micra TPS is about one-tenth the size of a regular pacemaker. (Medtronic) (4 of ) Medtronic's new Micra TPS is about one-tenth the size of a regular pacemaker. (Medtronic) Worlds tiniest pacemaker debuts: about 1 inch long NORTH BAY BUSINESS JOURNAL | December 13, 2017 The pacemaker dates back to the early 1940s. They were external devices to help regulate heart rhythm, but were large, bulky, relied on external electrodes and had to be plugged into a wall outlet. They could also fail during a power blackout. In the mid-1950s, Dr. C. Walton Lillehei, a pioneer in open-heart surgery at the University of Minnesota Medical School, and his colleagues set out to develop a better system with the help of Medtronic engineers. One of those was Earl Bakken, who developed a new kind of pacemaker that was not much larger than a paperback book. He used parts from electrical devices he had in the shop. The devices circuitry was based on a design for a transistorized metronome he had seen in a trade publication. The pacemaker was powered by mercury batteries, provided a 9-volt DC pulse, and could easily and comfortably be worn by young patients, according to Medtronic. The original Bakken pacemaker was tested in the University of Minnesotas laboratory, then applied to a pediatric heart patient. The device immediately restored the childs heartbeat to near normal. Within days, the childs heart resumed a normal rhythm on its own, and the pacemaker was removed. In the U.S., the first implantable pacemaker was developed in 1960. Billed as the worlds smallest pacemaker, Medtronics new Micra TPS (Transcatheter Pacing System) is about the size of a large vitamin capsule. At about one- Continue reading >>
Can Medtronic's Leadless Pacemaker Improve The Company's Share In Cardiac Rhythm Management?
Can Medtronic's Leadless Pacemaker Improve The Company's Share In Cardiac Rhythm Management? In a recent clinical trial, Medtronic's wireless pacemaker, the Medtronic Micra Transcatheter Pacing System, was proven to be significantly more effective than current options with a high degree of efficacy. Data from the findings will be used to seek approval from the U.S. regulatory authority, the FDA.Unlike the traditional pacemakers that use a lead wire to connect to the heart, the Micra pacemaker is leadless and eliminates the complications that can arise if a lead wears out or breaks. Moreover, the device is very small and can be implanted endoscopically, rather than through conventional surgery. By reducing the surgery costs, decreasing lead-related complications and easing the process of implantation, Micra can see increased adoption among heart patients, who depend on pacemakers to control their heart-beat. With the release of the study, moreover, fiercemedicaldevices.com and The Journal of the American Medical Association described the benefits of leadless devices on their respective website and publication . The outlook for Medtronic's cardio vascular group is all the more positive, suggesting the company can stabilize and even reverse the decline in its cardiac rhythm management market share with the strong adoption of leadless Micra. See our complete analysis for Medtronic here Medtonic's expects Micra to decrease the number of complications involved in using a pacemaker by taking lead out of the system and decreasing the size considerably, which eases the process of implantation. Unlike the traditional pacemaker that is implanted through surgery, the Micra pacemaker can be implanted through a catheter, eliminating the need of a surgical process and reducing the co Continue reading >>
The Pacemaker Inside Me: What I Learned About The Industry As A Cardiac Patient
The pacemaker inside me: What I learned about the industry as a cardiac patient My cardiologist stepped out of the exam room and returned with a medium-sized cardboard box that rattled as she walked. The contents: a few dozen watch-sized, titanium-encased implantable pacemakers of various shapes and thicknesses. As of Jan. 2, 2014, a version of one of the many pacemakers I examined in that cardboard box has become a part of me, implanted under my right clavicle, with two wire leads snaked through two veins and into my heart. My knowledge of the industry gave me the ability as a patient to ask questions that helped me choose a safe, reliable pacemaker and lead option. This led to a quick realization that true choices for most U.S. pacemaker patients remain limited, despite the marketing hype around innovation in the industry. U.S. pacemaker patients get an odd combination of technological wizardry and clunkiness. The market also carries a built-in risk for complications--however small--that easily throws extra expense onto the overall healthcare system. As I write this, I have had my initial pacemaker surgery, plus two additional procedures to address a wire that pulled out of its proper spot in my heart. Here's what I've learned, or been reminded of, so far: How the big three dominate the global market for pacemakers While a number of companies make sophisticated, reliable pacemakers for the global market, I was particularly interested in a product from a small international outfit. My doctor expressed that that option was viable but not practical. She and the hospital with which she is affiliated generally rely on pacemakers and leads from the three biggest cardiac device makers: Medtronic ($MDT), St. Jude Medical ($STJ) and Boston Scientific ($BSX). Here's why: The B 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 >>
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 >>