| Developers: | Medtronic (Medtronik) |
| Branches: | Pharmaceutics, medicine, health care |
Content |
CoreValve is the system of transkateterny prosthetics of the aortal valve of heart developed by Medtronic company. The technology of implantation of the aortal valve is executed by chreskozhny access, without carrying out artificial blood circulation.
2019: U.S. authorities cover Medtronic and do not announce death from devices for replacement of the aortal valve
At the end of December, 2019 the Kaiser Health News edition published results of investigation which showed that the Food and Drug Administration (FDA) maintains the closed database of the lethal cases connected with transkateterny devices for replacement of the aortal valve (TAVR) of lines of Coretalve Medtronic and Sapien Edwards Lifesciences.
Both devices were originally intended for patients with contraindications to open heart operations. However afterwards regulatory bodies approved their use and at patients with average and low risk. TAVR devices are installed chreskozhno, at the same time the doctor uses a catheter for carrying out the device in heart that potentially reduces number of complications after transaction.
However, judging by data of Kaiser Health News, the regulator maintains the closed register of the undesirable phenomena connected with TAVR. The similar case was connected with other database of "the alternative summary reporting" which was unavailable to the public and contained millions of messages about the undesirable phenomena and failures in operation of medical devices. As soon as existence of this database was published, regulatory bodies officially published information which is contained in it.
Recently detected register was created in 2010 and contains all reports on the undesirable phenomena connected with six different TAVR devices. In the report of Kaiser Health News, however, only structures of Medtronic and Edwards are specified, and regulatory bodies do not respond to the requests for the additional information.
It is known that such registers are often maintained by medical communities which "anonymize" data and share them with the members and control authorities, but not with the public. The register detected by media is known as STS/ACC TVT Registry and is the main storage of the clinical data connected with TAVR devices. It was created by Society of thoracic surgeons and the American college of cardiologists for monitoring of security of devices and tracking of post-registration result of treatment using TAVR.
FDA accepts hundreds of messages about lethal cases which are registered in spreadsheets of the register of STS/ACC TVT. The news agency reported that the CoreValve device of production of Medtronic is connected with more than 5800 lethal cases since 2014, and messages about 2400 fatal cases since 2016 are provided in the database for the Sapien Edwards device. At the same time the companies publish absolutely other digits, underestimating prevalence of the undesirable phenomena or specifying fatal cases in the section of normal injuries or faults of devices. In October, 2019 the research published in JAMA Internal Medicine showed that Abbott used the same approach at a reporting preparation about the undesirable phenomena connected with transkateterny devices for replacement of an aorta or the mitralny valve.
Medtronic reported to Kaiser Health News that in case of detection of fault of the devices the company "makes all efforts" for the due notice of regulatory bodies, health workers and the public. The company also stated that about 40% of messages about the fatal cases registered in the register were not followed by the additional information. Such restrictions complicate assessment of real communication of these death using above-mentioned devices. Edwards supported Medtronic and also noted that transkateterny transactions on valves prolonged life and increased its quality at 600,000 patients around the world.[1]
2017
Comparison with heart valves of Boston Scientific
In May, 2017 Boston Scientific announced superiority of the heart valve of Lotus over the competing CoreValve developed by Medtronic company. Devices were compared in a research which results were published on the Congress of the European association on chrezkozhny cardiovascular interventions of EuroPCR 2017 in Paris.
912 patients with high and extremely high surgical risk which shows transkateterny prosthetics of the aortal valve of heart participated in a research. In clinical trials prostheses of Lotus, CoreValve and CoreValve Evolut were used.
In primary endpoints of efficiency evaluation considering the frequency of fatal cases, development of the disabling stroke and an okoloklapanny regurgitation within a year, Lotus showed result better: Against 29% CoreValve has 16.7%. On an endpoint of security (frequency of lethal outcomes from the various reasons, a stroke, life-threatening bleedings, the second or third stage of a sharp renal failure or serious vascular complications in 30 days) indicators of products were similar.
In secondary endpoints of efficiency evaluation of Lotus gained only 2% that it is less in comparison with CoreValve (11.1%) which in this comparison was much more unsafe.
 | We are very inspired by system effectiveness of Lotus in this research as it represents the most important part of clinical proofs of efficiency of the platform — the executive vice president and the director of global medical business of Boston Scientific Ian Meredith says. — We believe that these data together with results from other researches, can illustrate even stronger unique clinical advantages which this system offers doctors for treatment of patients.[2] |  |
Transaction in the Nizhny Novgorod cardiocenter
At the end of March, 2017 in Nizhny Novgorod "Specialized Cardiac Clinical Hospital" (SCCH) there took place the first heart operation using transkateterny aortal CoreValve valves.
According to the chief physician of SKKB Anton Maximov, the uniqueness of transaction is that the aortal valve is replaced without opening of a cavity of heart and use of artificial blood circulation — such transactions took place in the region for the first time.
| | This technology appeared only in the 21st century, the first transaction is executed in 2003 in France, now it wins the world. But transaction is possible not for all patients but only those who normal transaction with artificial blood circulation cannot be offered: these are the people of advanced age, people having associated diseases, such as renal failure, oncological diseases, diabetes — Maximov reported. | |
In the cardiocenter the help meeting where the management of clinic will provide information on techniques of treatment of the cardiopathologies applied in the center, and about methods of treatment and prevention of diseases of a cardiovascular system will be held. Such method of implantation is suitable more for patients of a retirement age to whom other treatment is already unavailable.
As the Minister of Health of the Nizhny Novgorod Region Irina Pereslegina noted, operations are performed for residents of Nizhny Novgorod free of charge. According to her, by the end of March, 2017 of 84% of all types of hi-tech treatment the Nizhny Novgorod patients can receive, without leaving areas.[3]
Notes
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