Category: Community

EDWARDS SAPIEN 3 TAVR RECEIVES FDA APPROVAL FOR LOW-RISK PATIENTS

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[vc_row][vc_column][vc_column_text]The heart valve systems are used to treat severe, symptomatic aortic stenosis (AS) patients who are determined to be at low risk of open-heart surgery.

Speaking after the approval, Director of the Centre of Interventional Vascular Therepacy at New York-Presbyterian/Columbia University Medical Centre, Martin Leon, said the “FDA approval of SAPIEN 3 TAVR will expand access across this proven therapy, which should be considered the preferred treatment for the majority of low-risk severe AS Patients.”

The SAPIEN 3 TAVR’s low-risk approval was base on data from the landmark PARTNER 3 Trial, an independently evaluated, randomised clinical trial comparing outcomes between TAVR and open-heart surgery. TAVR with the APIEN 3 system achieved superiority, with a 46 percent reduction in the event rate for the primary endpoint of the trial, which was a composite of all-cause mortality, all stroke and rehospitalization at one year.

The data were presented in March at the American College of Cardiology’s 68th Annual Scientific Session and simultaneously published in the New England Journal of Medicine.

Edward’s corporate vice president for transcatheter aortic valve replacement, Larry Wood, said severe AS was a debilitating disease that often goes undiagnosed and undertreated.

“This approval is a significant milestone and will allow all patients diagnosed with severe AS to be considered for TAVR based on their individual preferences and anatomical considerations versus traditional risk scoring,” Mr Wood said.

The SAPIEN family of transcatheter heart valves have treated hundreds of thousands of patients worldwide since 2007, when the SAPIEN valve was first commercially approved in Europe. The SAPIEN 3 TAVR system builds on Edwards’ decades of experience in the development of tissue heart valves, and the proven benefits of the Edwards SAPIEN valves. This low-risk approval covers the SAPIEN 3 and SAPIEN 3 Ultra valves in all sizes.[/vc_column_text][/vc_column][/vc_row]

First Female President of the Cardiac Society

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[vc_row][vc_column][vc_column_text]Clara Chow is Professor of the Faculty of Medicine and Health at the University of Sydney and is Academic Director of the Westmead Applied Medical Research Centre and Program Director Community Based Cardiac Services and Cardiologist at Westmead Hospital, Sydney.

The Cardiac Society of Australia and New Zealand is the professional body for cardiologists and those working in the area of cardiology including researchers, scientists, cardiovascular nurses, allied health professionals and other healthcare workers.  The Society is established with the object of promoting the highest standards of education, training, research and practice in cardiovascular medicine and surgery as well as promoting the prevention and control of cardiovascular disease in human beings.

CSANZ President, Professor Len Kritharides, said “the CSANZ is very fortunate to have Clara as its incoming President. She is an outstanding Cardiologist and Researcher and will bring great energy and insight to the role.”

“I am excited and proud to take up the President-elect position of the Cardiac Society of Australia and New Zealand. I think this shows the strong commitment of our society to change and addressing the challenges of diversity for our members as well as our patients,” Professor Chow said.

Prof Chow will serve as President-elect for 12 months and will take up the role of President in August, 2020.[/vc_column_text][/vc_column][/vc_row]

MEDTRONIC NAMED ON THE 2019 AFR BOSS MOST INNOVATIVE COMPANY LIST

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For the first time in 2019, organisations were ranked directly against their peers across ten industry lists. All lists can be viewed here.

Medtronic ranked #3 on the Health Industry list, from over 800 nominated organisations across Australia and New Zealand. The assessment measures a top innovation implemented in the past twelve months. Specifically, the judges look at how valuable the problem is that the innovation is solving, the quality and uniqueness of the solution, and the level of impact that the innovation has had. Inventium also assesses internal elements such as innovation culture, strategy, resources and process, which demonstrate a sustainable and repeatable approach to innovation.

Medtronic was recognised for its MiniMedTM 670G system launched in early 2019 – an insulin pump system which automatically self-adjusts to deliver people living with type 1 diabetes precise amounts of insulin when they need it. Medtronic also made the list thanks to the exceptional innovation practices adopted by the organisation like fostering a strong internal culture of innovation and engaged employees as part of their leadership expectations and employee development; as well as supporting local medtech incubators and STEM initiatives with local schools and universities.

“Since 1949, meaningful innovation has been etched into everything we do. This spirit of innovation is evidenced in our technologies, and the way we show up to work every day to improve community health outcomes,” said Tim Fortin, Vice President and Managing Director, Medtronic Australasia.

“Globally our therapies help more than two people every second, delivering on our Mission to alleviate pain, restore health, and extend life. At Medtronic, we believe patient-focused innovation – and strong partnerships – remain key to an even better, more impactful future; and that nurturing an innovation mindset supports our team to operate at the highest standards when challenging the status quo to go beyond medical devices to deliver better outcomes to more patients more efficiently.”

 

About The AFR Boss Most Innovative Companies List

The AFR BOSS Most Innovative Companies list (previously the BRW Most Innovative Companies list) is now in its eighth year. The list ranks the most innovative organisations in Australia and New Zealand, and is the only national list of its kind. For the first time in 2019, the list was broken down into 10 industry categories, effectively ranking organisations against their peers. The list is judged and compiled by Inventium – Australia’s leading innovation consultancy. Inventium uses a unique, scientifically proven approach to help organisations grow through innovation. In 2019, the list comprised of ten industry lists of ten, compiled from over 800 nominations, and 400 shortlisted organisations.

GRATTAN INSTITUTE WRONG ON DEVICES

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[vc_row][vc_column][vc_column_text]The medical devices industry has been the sole contributor to reducing the pressure on private health insurance premiums, through the Agreement signed with the Commonwealth in 2017.

This means that, for example, in February 2020, hip replacements will have their 3rd price cut in 4 years.

“Costs for medical devices have fallen in every quarter since the Agreement with the Federal Government signed in 2017,” said Ian Burgess, CEO of the Medical Technology Association of Australia.

“The medical devices industry has been the sole contributor to reducing the pressure on premiums, with another round of price reductions to come in January 2020,” Mr Burgess said.

The Agreement will save private health insurers $1.1 billion in payments for medical devices over the next four years and helped deliver the lowest private health premium increase in 18 years in December 2018.

The benefit paid per device has declined by 1% per annum since 2013, with any increase in expenditure on devices due entirely to an increase in demand.

According to recent APRA data, compared with the March 2018 quarter, March 2019 quarter statistics show that the average benefit paid for all prostheses has gone down 9%.

The Prostheses List is a key part of the value proposition of private health insurance and ensures that surgeons can choose the best available device for privately insured patients without the option being restricted by health funds.

The Prostheses List is a key driver of choice for privately insured patients, enabling surgeons to choose the best possible device for each individual patient.

“The Prostheses List ensures that patient outcomes, rather than insurer profits, are at the centre of patient care. Bundling payments, as proposed by the Grattan Institute, simply serves to incentivise the lowest cost option and restrict access,” said Mr Burgess.

“To make comparisons with international prices is like comparing apples with oranges, as the price of devices can vary due to range of factors, including differences in healthcare systems, purchasing arrangements, geography and other economic factors.

“The medical technology industry believes access to a full range of medical technology is the most valuable component of a private health insurance policy and we’re committed to doing what we do best – assisting patients to lead healthier and more productive lives,” Mr Burgess concluded.[/vc_column_text][vc_single_image image=”3903″ img_size=”full”][/vc_column][/vc_row]

Last chance to nominate – Australian MedTech Industry Awards

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The categories are:

Kerrin Rennie

The Kerrin Rennie Award for Excellence in Medical Technology – Improving Quality of Life was established to recognise and profile the innovative and extraordinary contribution of medical technology in improving health outcomes of Australian patients.

Outstanding Achievement

This award recognises an individual who has contributed in an exceptional way to the medical technology industry in Australia. This may be evidenced through their contribution to industry development, improvement in patient outcomes or excellence in leadership or innovation.

Women in MedTech (WiMT)

The WiMT Awards are presented to an individual and a company who have both been leaders in advancing or achieving a significant result in the WiMT mission or goals within their company or the industry.

Nominate on the MTAA website.[/vc_column_text][/vc_column][/vc_row]

HAIL TO THE (NEW NSANZ) CHIEF

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[vc_row][vc_column][vc_column_text]Melbourne-based Pain Specialist and Anesthetist, Dr Nick Christelis, has hit the ground running in his new role as NSANZ President, spearheading the development of several policies promoting best practice within the neuromodulation industry.[/vc_column_text][vc_separator][vc_column_text]

What is Neuromodulation?

Neuromodulation, also known as Spinal Cord Stimulation, is a minimally invasive and reversible therapy that may prove an effective, additional or alternative option for those who have tried, and failed, conservative pain management treatments. It works by intercepting pain signals as they travel along the nerve fibres through the spinal cord, before they reach the brain.

[/vc_column_text][vc_separator][vc_column_text]One of Dr Christelis’ first actions as president was to announce NSANZ had been awarded charity status by the Australian Charities and Not-for-Profit (ACNC), recognising its invaluable role in striving to uphold the professional practice of neuromodulation across the Tasman, and supporting the estimated one-in-five Australians and New Zealanders living with chronic pain.

Dr Christelis said he was delighted the NSANZ had been award charity status, allowing it to fund and promote further research, educate doctors and establish a neuromodulation device registry.

“I am genuinely excited at the prospect of further consolidating our organisation’s significant success to-date and continuing to strengthen our position as professional pain management industry leaders”, Dr Christelis said.

“We are currently drafting policy documents and guidelines outlining standards for safe and effective neuromodulation practices, encompassing device-related education, training, implantation techniques and management.”

An estimated 3.24 million Australians, including children and adolescents, live with the debilitating affects of chronic pain. Chronic pain is neither preventable, nor the consequence of poor health choice. The condition affects both young and old and can significantly impact a person’s physical and mental health, often leading to social isolation and loss of purpose.

According to a Deloitte Access Economics report released by Pain Australia earlier this year, the 2018 estimated total financial cost of chronic pain in Australia was $73.2 billion, comprising $12.2 billion in health system costs, $48.3 billion in productivity losses, and $12.7 billion in other financial costs.[/vc_column_text][/vc_column][/vc_row]

Enough Talking – Time for Action on Long-Term Health Policy Vision

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Dr Bartone begun his address by talking of his own personal story and experience with the health system – his mother’s patient journey.

He spoke of being in Brisbane in November 2018 to launch the AMA Indigenous Health Report Card when, that same night, his elderly frail mother fell at home and was admitted to hospital.

“She has not been able to return home since that night. She was eventually admitted to an aged care facility”, Dr Bartone said.

“It gave me, as AMA President and a community GP, an unwelcome front row seat to the care journey of a loved one in our health system. Unfortunately, my mother’s story is not uncommon. It is the same story for many patients in our health system.”

Dr Bartone discussed the significant changes to the health system in 2018, including the 2019 election which he mentioned that “two months on from the election, the need for significant health reforms remains – and it must still be the Government’s highest priority”.

The speech slammed the current health system for its under-funding, under-resourcing, poor access, waste, inequality, and inefficiencies. “From maternity services to primary care, prevention to public hospitals, private health insurance to the Medicare Benefits Schedule, mental health care to indigenous health to aged care” he didn’t hold back on his criticisms.

Dr Bartone said that, for Health Minister Hunt, the time for talk was over. It was now time for action.

Included in his critique of the health system, Dr Bartone called on the Federal Government to ensure the private health sector remains efficient, robust, and productive.

The private health insurance sector has experienced 15 successive quarters of decreasing coverage despite a comprehensive Government review and the transition to the new Gold, Silver, Bronze and Basic policy structure.

However, Dr Bartone said he believes the situation is even worse, citing the “increases in premiums averaging 3 to 5 per cent a year, when wages growth is firmly stuck at around 2 per cent”.

“Sooner or later, the number of people with private health insurance will fall further – and dramatically. This would mean the option of private hospital access would be unaffordable for many Australians,” Dr Bartone said.

“This reform needs to start now – we can’t wait for another dozen quarters of decline. The death spiral is already underway.”

Dr Bartone rounded out his address with a clear call for economic rationalism, highlighting that health care in Australia employs 14 per cent of the nation’s total workforce.

“Driving economic activity through our largest workforce sector would also add extra capacity in general practice, hospitals and other front-line areas.”

A Conversation with Sir Andrew Dillon

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[vc_row][vc_column][vc_column_text]Sir Andrew joined the NHS in 1975 and has held a number of senior management positions, including General Manager of the Royal Free Hospital and Chief Executive of St George’s Healthcare NHS Trust. He joined the National Institute for Health and Care Excellence as its founding Chief Executive in 1999.[/vc_column_text][vc_separator][vc_column_text]

Question 1 : What is NICE and your role?

 

Question 2: What is health technology assessment (HTA)?

 

Question 3: What are the processes that a medical device could go through when being assessed by NICE?

 

Question 4: Has the availability of clinical data for the evaluation of medical devices been a challenge and if so, what has been the approach?

 

Question 5: What role do medical device registries play in the ongoing evaluation of the cost effectiveness of devices?

 

Question 6: What does value-based health care mean to you?

 

Question 7: How can the medical device industry become a better participant with HTA when moving into assessment?

 

Question 8: What have been the challenges to reimbursement in HTA with software as a device?

 

Question 9: How can the medical device industry help with challenges in the uptake of good cost-effective technologies?

 

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Edwards Lifesciences Customer Service Team In The Running For Top Prize

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[vc_row][vc_column][vc_column_text]The Australian Service Excellence Awards established by Customer Service Institute of Australia is the premier customer service awards event. The awards are a way to recognise best practice and innovation in customer service, highlighting its importance in today’s business climate.

In addition, Edwards Lifesciences has been nominated as a finalist at the Australian HR Awards for Employer of Choice (1-99 employees).

The Australian HR Awards celebrate the outstanding achievements of the country’s top HR leaders, companies and teams. This year, HRD received hundreds of nominations for the 20 categories that recognise outstanding contributions of best practice and leadership from right across Australia.

The winners will be announced in September and October.

Managing Director of Edwards Lifesciences ANZ, Pat Williams said:

“I am so thrilled that our customer service team has been selected as finalists. This is a recognition for their commitment to living our patient-centered Credo.

“And to be recognized as an Employer of Choice after two years of being a finalist in the Best Learning & Development category is a testament to our HR team.”[/vc_column_text][/vc_column][/vc_row]