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...
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...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).
"Syncardia Temporary CardioWest Total Artificial Heart (TAH-t) - P030011." U S Food and Drug Administration Home Page. Web. 16 Oct. 2011. .
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.
These programmers communicate with the pacemaker via wireless radio frequency as well as telemetry to make device adjustments and monitor device functions. Physician programmers require no authentication to program pacemaker devices [15]. This is true for all pacemakers. The lack of required authentication is a point of concern because of the potential for risk. As was mentioned, pacemaker manufacturers warn of prolonged exposure to cellphones, metal detection systems, and other electrical devices for risk of misinterpretation by the pacemaker. The electrical impulses these devices emit could be read by the pacemaker as a heartbeat which could cause the device to malfunction or fail [17]. Deliberate attacks on pacemakers have been tested and provide troubling results. Within a 50-foot proximity, an attacker can deliver a lethal 830v jolt to a user’s heart from a laptop [13]. On the hard drives of two pacemaker devices both encrypted and unencrypted data was found by researchers for the technology research company WhiteScope. The researchers found that one unnamed pacemaker device stores unencrypted PHI such as patient and physician names, treatment data, and, most concerning, patient social security number [15]. This information can be collected and sold through black market
With this improvement, Dr. Willem J. Kolff, the head of the artificial developmental program at the University of Utah, and Dr. William DeVries, the head cardiac surgeon at the University of Utah, decided to take this device further. They wanted to develop a heart based on the heart tested in farm animals, to place into a human. This was done with the help of Dr. Robert Jarvik who developed the Jarvik-7. This device was made of plastic and aluminum. With all that they had accomplished, the staff at the University of Utah’s artificial development program still had to wait 2 years before they found the right candidate for the project.
..., Welsh R, Feindel C, Lichtenstein S. Transcatheter aortic valve implantation: a Canadian Cardiovascular Society position statement. Can J Cardiol. 2012;28:520-8.
Many experiments later, a device was born. In the late 1960s a man by the name of Carpentier developed the first annuloplasty ring (Christenson & Kalangos, 2009). He created the device in an attempt to reduce the size of the mitral valve and as a result decrease the severity of the mitral regurgitation (Lantada et al., 2009). Annuloplasty rings are designed to aid in the repair of the mitral valve. The repair of a mitral valve is preferred over complete replacement. This is mainly due to the fact that the patient is not required to use long term drug therapy following surgery (Buckner et al., 2010). After a valve has been repaired, the annuloplasty ring is sutured onto the patient’s native mitral annulus. The ring not only reconstructs the shape of the mitr...
Endovascular stent graft repair is designed to help reinforce a weakened aorta. Endovascular surgery is performed inside the aorta using thin, long tubes called catheters to place a stent surrounded with a fabric liner. Endovascular stent grafting uses an endovascular stent graft to reinforce the wall of the aorta and to help keep the damaged area from rupturing and developing into a potentially serious health problem that can be fatal and cause massive internal bleeding.
According to Batshaw, Roizen, and Lotrecchiano (2013), patent ductus arteriosus (PDA) is “the persistence of a fetal passage permitting blood to bypass the lungs” (p. 745). This is an inherited heart condition in which the ductus, a small pathway between the pulmonary and the aortic, valves remain open. This cardiovascular problem usually occurs in low birth weight infants. The blood vessels usually naturally closes after birth (Batshaw et al., 2013, p. 96). It becomes atypical if it remains open after the neonatal period. The structure usually closes in typical developing newborns around the initial 24 hours, and anatomical closure is supposed to follow several weeks later (Stanford Children’s Health, 2015). At the point when the ductus arteriosus stays open, the blood from the oxygen-rich aorta blends with the oxygen-poor pulmonary artery causing the higher chance of blood pressure in the lung pathways (U. S. Department of Health and Human Services, 2011). Certain children who have patent ductus arteriosus may be given medication, relying upon the circumstance to standardize the blood and oxygen levels until surgery is performed. Doctor can treat this condition by providing pharmaceutical medicine, catheter-based procedures, and surgery (U. S. Department of Health and Human Services, 2011).
Robert Jarvik is the person who invented the first Artificial Heart to be used on a human being. Robert Koffler Jarvik is an Inventor, Physician, and Biomedical Engineer (faqs.org). He was born on May 11, 1946 in Midland, Michigan (encyclopedia.com). He was born to Norman Jarvik and Edythe Jarvik. As a kid he was always taking things apart to see how they work. He would sometimes watch his father in the operating room, which sparked an interest in him (encyclopedia.com). While Robert was still in high school he also invented the automatic stapler for surgery.
The company has over 46,000 devoted employees worldwide, 5,800 of those are scientists and engineers, dedicated to the promising research and innovation inside the three main groups of Medtronic Inc., the Cardiac and Vascular Group started in 1957, the Restorative Therapies Group, and the Diabetes Group. Both the Cardiac and Vascular and the Restorative Therapies groups are broken down further into four sub-groups. The Cardiac and Vascular Group is broken down into Cardiac Rhythm Disease Management (CRDM), Coronary, Structural Heart, and Endovascula and the Restorative Therapies Group is broken down into Spine, Neuromodulation, Diabetes, and Surgical Technologies (Medtronic, 2014). The Cardiac and Vascular Group alone, made 30% of Medtronic Inc.’s total revenue in 2014 at $8,765 million f...
There has been an effort to replace the foley catheter due to its age and problems that the device has such as
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...
Due to such safety concerns, the manufacturers are facing device recalls for the device such as DePuy Synthes, Stryker, Smith &Nephew, Biomet and Zimmer [2]. As the knee surgery is most common now a day i.e. around 7 million of Americans are living with the surgery. Moreover, the regulatory issues with the devices are leading to the serious issues to the public health with the implantable device. Considering the regulatory aspects, the knee joint prostheses were the post-amendments device classified into class III under section 513(f)(2) of the act. After the petition submitted by Orthopedic Surgical Manufacturers Association (OSMA), the Panel recommended that this device can be reclassified from class III to class II at the public meeting
Every year, thousands people get heart valve replacements for various health reasons. There are multiple options for replacement valves that can generally be put into two categories, mechanical and biological. One of the mechanical options from the 1970s and 1980s was the Bjork-Shiley valve, which became infamous because of the controversy surrounding its stress fracture failures. These failures resulted the death of about 400 people, causing the value to be taken off the market. Using various ethical standpoints, the decisions made surrounding this issue must be examine so that an incident like this will not occur in the future. Ultimately, the FDA should require either third party or FDA in-house testing in order to ensure the safety of a
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.