Medtronic (Minneapolis) and Edwards Lifesciences (Irvine, California) were not strangers in patent lawsuits. Edwards is specializing in the production of artificial heart valves and new hemodynamic monitoring technology, whereas Medtronic is specializing in the production of medical devices. In the past, the two companies have problems in patent infringement lawsuits over annuloplasty procedures and endovascular graft (1,2). However, currently another latest patent infringement lawsuit has been occurred and reported between Medtronic and Edwards Lifesciences. Edwards claimed that it has prior intellectual property rights on the new transcatheter aortic valve technology. Transcatheter aortic valve replacement or TAVR is the latest technology used principally for the treatment of aortic stenosis, a condition in which one of the major valves of the heart, the aortic valve, becomes tight and stiff, usually as a result of aging (3). Since many patients who need aortic valve replacement for aortic stenosis are too sick to undergo major valve replacement surgery, they are unable to get the treatment they need. With the transcatheter aortic valve, this issue is bypassed because this valve can be implanted in the heart by accessing the patient’s heart through an artery in the groin. The valve can be inserted through a wire that can be pushed to the heart and the old valve is simply pushed to the side when the new valve is implanted. This technology has been in use in the US with Edwards’ Sapiens valve since 2011 and has saved the lives of many patients with aortic stenosis (4). Medtronic’s CoreValve uses similar technology and has won patent fights in Europe and has been in use internationally. However, within U.S., Medtronic has not been... ... middle of paper ... ...Lifesciences' Andersen Patent. 2010:2014. (7) Hall B. Patents and Patent Policy. 2007. (8) Morse H. SETTLEMENT OF INTELLECTUAL PROPERTY DISPUTES IN THE PHARMACEUTICAL AND MEDICAL DEVICE INDUSTRIES: ANTITRUST RULES. (9) Allison JR, Lemley MA, Moore KA, Trunkey RD. Valuable patents. Geo.Lj 2003;92:435. (10) Gold R. Are Patents Impeding Medical Care and Innovation. 2010. (11) Alten B. Left to One's Devices: Congress Limits Patents on Medical Procedures. 1998;8(3). (12) Court Report:Medtronic Pays Edwards $83.6m Owed for Patent Suit. (13) Edwards up, Medtronic Down after Court Hits Corevalve. 2014; Available at: http://www.veooz.com/news/DH4sahZ.html, 2014. (14) Chieffo A. Transcatheter Aortic Valve Implantation with the Edwards Sapien Versus the Medtronic Corevalve Revalving System Devices: A Multicenter Collaborative Study: The Pragmatic Plus Initiative. 2013;61(8).
A). Abiomed got an approval for their fully implantable artificial heart through and HDE approval. The purpose of the HDE is that it helps small numbers of patients who have no alternatives. However, the company is unable to sell more than 4,000 devices per year and must be able to monitor every patient who receives their device. First, Abiomed was able to convince the Office of Orphan Products Development (OOPD) that their device can be designated as a HUD. Next, they were able to submit their application (for a fee of $0). This application is very similar to that of PMA, but doesn’t require to contain results that the device is effective for its intended purpose (fda.gov). However, the application does need to show that the device does not pose a risk and that the health benefits outweigh the risk or injury after use. Additionally, no other devices are available for treatment and that they could not otherwise bring it to market. Approximately after 75 days of review time, CDRH approved AbioCor. Next, Abiomed had to obtain an IRB approval before they would be able to use Abiocor at any facility.
The records have been reviewed. The member is an adult male with a birth date of 02/09/1959. He has a diagnosis of ischemic cardiomyopathy. His treating provider, Maria Costanzo, MD, recommended the Zoll LifeVest (wearable cardioverter defibrillator) for the following dates of service 09/02/2015, 10/02/2015, 12/02/2015, 01/02/2016-02/02/2016 (totaling 4 units).
The development of the artificial heart began in the early 1950’s. The initial prototype, developed in 1970’s by the artificial developmental staff at the University of Utah, allowed 50 hours of sustained life in a sheep. Although this was called a success, the implantation of the artificial heart left the sheep in a weakened state. It wasn’t until late 1970’s and the early 1980’s where the improvement of the artificial heart actually received attention as a possible alternative to a heart transplant. The remodeled product of the early 1970’s did more than just the 50 hours of sustained life; it enabled the cow to live longer and to live a relatively normal life, with the exception of a machine attached to the animal.
..., Welsh R, Feindel C, Lichtenstein S. Transcatheter aortic valve implantation: a Canadian Cardiovascular Society position statement. Can J Cardiol. 2012;28:520-8.
“US Markets for Heart Valves.” SAGE Sourcebook of Modern Biomedical Devices: Business Environments, 2007. 21 April 2011.
Coronary artery bypass graft surgery is a procedure that can be life-saving for patients with heart disease, but it also carries risks after the procedure that can impact patient outcomes negatively. Because over 395,000 Americans have CABG surgery each year, and the risk-adjusted mortality rate for patients is 2%, according to Centers for Disease Control (CDC) statistics, health care professionals must find ways of reducing risks and complications to improve the outcomes for many patients (Ferguson, 2012). Heart disease is often comorbid with other conditions, like lung disease, peripheral arterial disease, hypertension, and diabetes, which can raise the risk of complications (Ferguson, 2012; Nejati-Namin, Ataie-Jafari, Amirkalali, Hosseini, Sheik Hathollahi, & Najafi, 2013). Complications that can arise following surgery include atrial fibrillation, prolonged inflammatory reactions, a build up of fluid near the heart, accelerated atherosclerosis, and nearby vein or artery blockage (Gokalp, Ilhan, Gurbuz, Cetin, Kocaman, Erdogan, & … Satiroglu, 2013; Ferguson, 2012; Scheiber-Camoretti, Mehrotra, Ling, Raman, Beshai, & Bowman, 2013; Sicaja, Starcevic, Sebetic, Raguz, & Vuksanovic, 2013). These complications can lead to increased lengths of stay, increased readmission rates, risk of further complications, failure of the bypass graft, cognitive dysfunction and memory loss, patient suffering, and even death (Ferguson, 2012; Gokalp et al., 2013; Sicaja et al., 2013). In turn, nurses, other care providers, and institutions may face negative consequences themselves, including a risk of lawsuits, increased employee workload, higher per-patient costs, reduced or withheld private insurance, Medicaid, and Medicare reimbursements, auditing...
The company prides itself on evidence based practice and utilized this to guide their decision making. With this mindset, the company has realized significant gains in quality services in that the patients receive very high level care. Typically, they are in the 87% percentile for outcomes in any given year. The company has clinical specialties of cardiology, orthopedics,
The uncle of my friend who had a pacing device inserted in his heart died last month.
Our goal was to maintain adequate fluid in the vascular space in order to maintain a blood pressure adequate for each patient while avoiding complications. During our evidenced-based research we obtained information on a Crit-Line Blood Monitoring System. We performed a work flow analysis prior to the implementation of this tool then created a redesign process to evaluate this piece of technology into our practice. We ran into a few obstacles in regard to a time line for training, and the overwhelming feeling of learning a new piece of technology when patient care was so demanding. We worked through the obstacles and utilized the technology towards achieving our goal. We tried to purchase more monitoring systems because it was evident it optimized fluid removal and reduced the frequency of adverse reactions. We ran into financial obstacles with money being tight as we close our fiscal year. It is in our plan to purchase more systems in fiscal year 2016. We need to give all Veterans the same opportunity to benefit from this technology with the ultimate goal of experiencing less symptomatic while achieving better outcomes. The staff had buy-in to this technology from day 1one and with the opportunity for them to learn at a steady pace they were better acclimated to the
Lidwell and Edgar H. Booth invented the first pacemaker. It was a portable device that consisting of two poles, one of which included a needle that would be plunged into a cardiac chamber. It was very crude, but it succeeded in reviving a stillborn baby at a Sydney hospital in 1928. The decades that followed, inventors came up with increasingly sophisticated versions of the pacemaker. However, these devices; which relied upon vacuum tubes; remained heavy and bulky, affording little or no mobility for patients. Colombian electrical engineer Jorge Reynolds Pombo developed a pacemaker in 1958 weighed 99 lbs and was powered by a 12-volt auto battery. Surgeons at the Karolinska Institute in Sweden were the first to place a fully implantable device into a patient in 1958. Rune Elmqvist and surgeon Ake Senning invented this pacemaker, which was implanted in the chest of Arne Larsson. The first device failed after three hours, the second after two days. Larsson would have 26 different pacemakers implanted in him. He died at the age of 86 in 2001, outliving both Elmqvist and Senning. In the world there are many heart attacks and as people grow they can get abnormalities in there heart(Medlineplus). When someone 's heart stops working it can be fixed with a pacemaker, it makes the heart beat properly. The artificial pacemaker is a wonder of modern science. A small, implantable device that regulates a human heartbeat through electrical impulses have saved millions of lives. The development of this vital medical device owes much to the advances in electronics and communications brought about by the Space Age.Pacemakers may be used for people who have heart problems that cause their heart to beat too slowly. A slow heartbeat is called Bradycardia two common problems that cause a slow heartbeat are sinus node disease and heart block. When your heart
A coronary artery bypass grafting (CABG) can be done if patient is experiencing chest pain, a valve repair or replacement can be done if there is a valve dysfunction present, a partial left ventriculectomy, and a cardiac transplantation available, but will only be done as a last resort. Some other options include temporary devices such as an IABP (Intraaortic Balloon Pump) which is used to increase cardiac output and coronary artery perfusion or a VAD (Ventricular Assist Device) which is for partial or complete heart failure. The VAD supports the patient’s failing heart and has the possibility to be placed long term if the option of transplantation is not available. The last type of treatment for CHF is a CRT or Biventricular Pacing which is used when conduction delays occurs in one of the bundle branches and has leads that are used to stimulate cardiac contraction and improve the cardiac output. (Linton, A.D.) There are also many other ways to help manage heart failure. Examples are maintaining a healthy weight, regular exercise, stop all forms of tobacco, limiting alcohol intake, and controlling hypertension. (Congestive Heart
The Northeast region consisted of 101 units (67 hospitals) from 4 states, the Midwest region consisted of 356 units (246 hospitals) from 9 states, the South region consisted of 433 units (271 hospitals) from 12 states, and the West region consisted of 211 units (124 hospitals) from 9 states. Across the participating units, catheter utilization was 31%. Utilization in the ICU at 61% was greater than the non-ICU at 20%. The West has the highest utilization in the non-ICU setting at 24% while the South had the highest utilization in the ICU at 63%. Compared with non-ICUs in the West, catheter utilization was significantly lower in non-ICUs in the Northeast (P=.001) and South (P=.007). Compared with ICUs in the West, catheter utilization was significantly higher in ICUs in all other areas: Northeast P =.02, Midwest P =.002, and South P <.001. Overall utilization did not vary by region after the hospitals characteristics were adjusted. Furthermore, several finding came from this nation study. It was found that catheter utilization remains common across the United States, with 20% in non-ICU settings and 61% in the ICU. Catheter appropriateness in the ICU was high across all regions, however; the study found that 30%-40% of catheters in the non-ICU setting may be placed without an appropriate indication. CAUTI rates were 2.5 per 1,000 catheter-days and did not differ by unit type.
Compared with LVADs, the TAH has several potential advantages, including the ability to assist patients with severe biventricular failure; a lack of device pocket and thus a lessened risk of infection; and the opportunity to treat patients with systemic diseases (eg, amyloidosis, malignancy) who are not otherwise candidates for transplantation. (http://emedicine.medscape.com/article/163062-treatment#d22 )
After her doctor’s visit that she reluctantly went to, she announced to the family that she was suffering from a damaged heart valve. We were all terrified about what would happen to her, but she assured us that the doctor said it could be fixed with a minimal risk.
...on. Timeline: 30 Years of Progress in Interventional Cardiology. The Society for Cardiovascular Angiography and Interventions Foundation. The Society for Cardiovascular Angiography and Interventions Foundation, 29 Sept. 2009. Web. 23 Mar. 2014. . A timeline of 30 years that explains the sequence of events that led to the modern technologies of invasive and interventional cardiology we have today.