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SPYRAL HTN program to evaluate renal denervation for uncontrolled hypertension - Healio |
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Medtronic announced the launch of a clinical trial program that will assess the use of renal denervation in patients with uncontrolled hypertension, according to a press release.
The SPYRAL HTN global clinical trial program comprises two prospective, randomized, sham-controlled trials: SPYRAL HTN-OFF MED and SPYRAL HTN-ON MED. The trials will be conducted simultaneously. In both, participants will undergo renal denervation by experienced operators with the Symplicity Spyral catheter and Symplicity G3 radiofrequency generator (Medtronic).
SPYRAL HTN-OFF MED will evaluate the impact of renal denervation on BP reduction without the use of antihypertensive medications. SPYRAL HTN-ON MED will assess renal denervation in patients with uncontrolled hypertension despite treatment with three antihypertensive medications; these drugs are not required to be prescribed at maximum tolerated medication dosages, a factor which may have contributed to variability in patient adherence and the large number of medication changes during the SYMPLICITY HTN-3 trial, according to the release.
The trials will include approximately 100 patients with moderate- to high-risk hypertension, enrolled at 20 centers worldwide, according to the release.
“Studying patients both on and off medication in a less severe and more homogeneous population than we saw in the SYMPLICITY HTN-3 trial is critical to gaining clarity on the true effect of this therapy,” Raymond Townsend, MD, director of the hypertension program at the University of Pennsylvania and a principal investigator for the new studies, said in the release. “By specifying medication classes and not requiring maximum tolerated doses, we can expect medication variability to be reduced, which will allow for a more controlled assessment of the impact of renal denervation in the presence of medication.”
Depending on the results of these trials, Medtronic may conduct a pivotal study to support a premarket application to the FDA, according to the release.
Disclosure:The SPYRAL HTN global clinical trial program is sponsored by Medtronic. Townsend is a principal investigator for the trials.
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'Mtnf's Intervention Boosts Renal Dialysis in Nigeria' - AllAfrica.com |
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By Yinka Shokunbi
Until recently, many Nigerians who suffer kidney failure couldn't live for long because of difficulty in kidney transplant and more importantly is the inadequate government dialysis facilities which could help in regular cleaning up of the body wastes; function hitherto carried out by the kidney.
The involvement of the MTN Foundation in partnership with Adcem Pharmaceuticals Limited in providing the needed dialysis machines to members of the public has no doubt helped give some relief to many patients who now have access to regular dialysis.
Speaking on the success of the MTNF's kidney support project, Managing Director, Adcem Pharmaceuticals Limited, Adeyemi Adewole described the intervention as one of the best things to happen to healthcare delivery in the country.
Adeyemi who is a trained pharmacist from ahmadu Bello University, Zaria noted, that the organisation in 1992 chose to get involved in providing sevices for patients with kidney diseases because it found out that there was a shortfall in service provision.
According to him, "In 1992, whilst researching on dialysis and kidney disease I discovered that services were inadequate and so we decided to partner with Fresenius AG Germany which has both pharmaceutical and medical equipment divisions, mostly specializing in kidney diseases", said Adeyemi.
He noted, "Through partnerships with corporate organizations, we have been able to execute a five-year turn-key and management service project with MTN Foundation, in which dialysis centres were established and managed in six geo-political zones in the country and the Heineken Africa Foundation HIV project, where a dedicated dialysis centre was established to cater for patients living with HIV and Hepatitis infections. This centre is situated at the Lagos University Teaching Hospital".
Although entrepreneurially, Adeyemi could be described as resilient, tenacious and quite passionate he however observes that there are numerous challenges to contend with in ensuring dialysis services are optimal in the country. "The first issue we have to contend with is lack of infrastructure (both physical and non-physical). We basically provide our businesses with the basic utilities needed to function. With non-physical infrastructure, I am referring to access to financing or lines of credit; the human resources needed to get the job done efficiently and effectively". He attributed the major causes of kidney disease in the country to rise in non-communicable diseases such as hypertension and diabetes, which are described as silent killers because they typically do not warn until they have progressed. "Therefore, a lot of Nigerians suffer from these non-communicable diseases without being aware, especially because we do not have a regular check-up culture. These diseases have become more common due to lifestyle choices, whereby we eat less of fresh organic food and physical activity is on the decline. Other reasons could be abuse of pain killers and other non-conventional medication usually described as traditional medicine, which could be harmful to the kidney. The proliferation of skin bleaching/lightening cream use could also be responsible", said Adeyemi. On the theme of this year's World Kidney Day, 'Kidney Health for All' Adeyemi suggested the sensitisation and education of individuals with apparently healthy kidneys, in order to place them on the right track and to avoid future illnesses, continuous professional development for medical personnel specializing in Nephrology, supporting the provision and establishment of renal care centres, subsidized/ free dialysis sessions (through reimbursement programmes) to enable people afford them as well as by reaching out to rural areas where people will not have access to the established centres and subsidized sessions. Adeyemi explained that most of the Dialysis machines it supplied MTNFoundation project were initially installed by expatriates but now locally done by its technical staff. Adeyemi commended MTNF's support in ensuring that renal failure is tackled in a sustainable manner saying, more individuals now have access to treatment through the provision of equipment and consumables. "The General Hospital, Alimosho, is the centre with the highest traffic as the centre as patients no longer need to travel so far for a service they are required to access three times a week. They are also used as screening points and providing awareness", he added. Adeyemi implored other organisations to imbibe the spirit of corporate social responsibility and help support more patients with kidney diseases through provision of more dialysis centres. "The joy on the face of any patient after undergoing a successful session of dialysis in any of the centres is usually contagious, because this has been tremendously subsidised by MTNF", Adeyemi averred.
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Non-functional dialysis unit shifted from district hospital to Kotkapura civil ... - Hindustan Times |
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Though there is an acute shortage of the staff, both medical and paramedical, at the civil hospital, Kotkapura, yet the district health authorities have, surprisingly, decided to shift the non-functional dialysis unit at the district civil hospital, Faridkot, to the sub-divisional hospital, Kotkapura. The unit is proposed to be made operational from the building, which was constructed for blood bank.
However, questions are being raised that if the unit could not be made operational at the district-level hospital, how could it be run successfully at the sub-divisional level hospital, which is already suffering from the shortage of staff.
At present, the sub-divisional hospital has only one medical specialist, who is on deputation with the hospital for three days a week from the sub-divisional hospital at Jaitu. There are no specialists in the eye and skin departments and three posts of emergency medical officers (EMOs) are lying vacant. The posts of pediatrician and psychiatrist are also vacant. The hospital is also facing a shortage of paramedical staff as well.
As the hospital has no specialists and emergency medical officers, it may not be able to operate the dialysis unit as well. "The government should first fill the vacant posts of doctors to serve the area instead of putting additional burden on it," said a source.
Patients are also suffering to the shortage of staff at the civil hospital as the authorities have sent some staff for training to the GGS medical college.
"I used to visit a private hospital. Of late, I started visiting the civil hospital, Kotkapura, to get treatment for diabetes, but when I visited it recently, I was attended to by a doctor, who only asked me to continue with the prescription telling me that the doctor concerned was on training. Surprising, the hospital does not have a weighing machine because the doctor asked to get my weight measured from outside," said a patient, wishing not to be named.
"The building, where the dialysis is proposed to be shifted was constructed for the blood bank. But, it has been found to be unsuitable for the blood bank as it does not meet specifications. A building should have a covered area of over 1,000 square feet to house the blood bank. But, it has only less than 800 sq feet. It raises the question on how the design of the building was passed when it did not meet the conditions. The health authorities have only shifted the non-functional dialysis unit from Faridkot to Kotkapura as a cover-up. However, we shall protest against it," said Devinder Neetu, a blood donor from Kotkapura.
The unit, which had two dialysis machines provided by the government, had been lying locked in district hospital at Faridkot for years allegedly due to the shortage of the staff and reluctance of patients to undergo dialysis there.
Dr Gaji Ujjair, senior medical officer at the civil hospital, Kotkapura, though admitted the shortage of doctors and paramedical staff, but claimed that the hospital would be able to run the facility."We have sent a doctor and two paramedical employees for training. It is in the interest of the area to have this unit here. It would not affect any daily functioning in the hospital. We are providing best service the staff available," he said.
"The doctor from Jaitu has been appointed in Kotkapura for three days a week and has been sent on 10-day training of the dialysis unit. He will hold additional charge of the unit. We will manage it efficiently despite the shortage of the staff in the Kotkapura hospital," said Dr Mohinder Singh Jassal, civil surgeon, Faridkot.
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Medicare continues doc payments despite SGR-required cut - NephrologyNews.com |
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Medicare physicians will still get their regular paycheck this week despite a law that was supposed to trigger a 21% cut in wages on April 1.
“CMS is taking steps to limit the impact on Medicare providers and beneficiaries by holding claims for a short period of time beginning on April 1,” The Centers for Medicare & Medicaid Services said in a statement. “Holding claims for a short period of time allows CMS to implement any subsequent Congressional action while minimizing claims reprocessing and disruption of physician cash flow in the event of legislation addressing the 21% payment reduction.”
Under current law, electronic claims are not paid sooner than 14 calendar days (29 days for paper claims) after the date of receipt.
Related:
Congress revives efforts to fix doc payment formula
Congress has been working on a replacement for the outdated sustainable growth rate formula for several months, pushing past the April 1 deadline with a final bill for President Barack Obama to sign. The bill permanently fixes Medicare reimbursement for doctors and includes a two-year extension for a popular children's health insurance program and money for community health centers.
The House passed the bill with a 392-37 vote, and it awaits a Senate review.
In addition to the Medicare Physician Fee Schedule adjustment, other provisions affecting providers were set to expire April 1, including exceptions to the outpatient therapy caps, add-on payments for ambulance services, payments for low volume hospitals, and payments for Medicare dependent hospitals.
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