U.S., EU regulators OK Endurant IIs stent graft from Medtronic | Monteris obtains $30M for robotic laser surgery platform | Medtronic grants natriuretic peptide rights to Capricor
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November 14, 2014
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U.S., EU regulators OK Endurant IIs stent graft from Medtronic
Medtronic's new Endurant IIs AAA endovascular stent graft, which is used to treat abdominal aortic aneurysms, has received FDA approval in the U.S. and the CE mark approval in Europe. The device, which is used with the Endurant II graft, features additional options for a better fit and simplified sizing decisions for easier pre-case planning. MedGadget.com (11/13)
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Are Commercial Operations Ready for IDNs?
In an era of consolidation, medtech companies must appeal to decision-makers other than doctors, especially non-clinicians at IDNs. But selling to IDNs strains commercial operations, and many are unprepared for the shift. This article illustrates the challenges for medtech commercial operations, and how they can thrive in a new market environment. Learn more.
Business & Market Trends
Monteris obtains $30M for robotic laser surgery platform
The first tranche of a Series B funding round has brought in $30 million for Minnesota-based Monteris Medical. The proceeds will go toward further marketing the firm's FDA-approved NeuroBlate system, a minimally invasive robotic laser surgery platform for killing brain tumors. MassDevice.com (Boston) (11/13)
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Medtronic grants natriuretic peptide rights to Capricor
Capricor Therapeutics secured the patent rights for the formulation and delivery of natriuretic peptides from Medtronic for an undisclosed amount. The firm will use the rights to start a clinical program to further develop Cenderitide, a natriuretic peptide, to treat post-acute heart failure. Middle Market Executive (11/14), MassDevice.com (Boston) (11/12)
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C. difficile test drives Q3 revenue growth for Great Basin
Utah-based Great Basin Scientific generated $404,390 in revenue during the third quarter, compared with $223,470 in the same period a year ago. The growth was attributed to increased demand for the company's Clostridium difficile test, which won FDA clearance in 2012. GenomeWeb Daily News (free registration) (11/13)
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International Developments
New Oncology signs cancer Dx deal in Singapore
The National Cancer Centre Singapore has entered into a cancer diagnostics partnership with Germany-based New Oncology for undisclosed terms. Under the deal, the cancer facility will use Neo, New Oncology's proprietary molecular testing platform, to provide personalized cancer therapy in Singapore. GenomeWeb Daily News (free registration) (11/12)
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Science & Health
Molecular Dx firm obtains up to $3.3M for Ebola diagnostic test
The Bill & Melinda Gates Foundation and the Paul G. Allen Family Foundation have given Cepheid a grant worth up to $3.3 million to develop the Xpert Ebola diagnostic test, which the company says probably would be offered for use on an emergency basis. The test would identify the Ebola virus using a person's saliva or a drop of blood. Reuters (11/13)
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Emerging Technologies
Roche's Group A strep test scores FDA clearance
The FDA has cleared Roche to market a polymerase chain reaction-based test that can identify the presence of Group A streptococcus bacterial DNA by analyzing throat swab samples. The cobas Strep A test takes just 15 minutes to generate results when used with the company's cobas Liat System, according to Roche. GenomeWeb Daily News (free registration) (11/13)
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Integra announces U.S. release of expandable interbody device
Integra LifeSciences said its first expandable interbody device, the FDA-cleared Integra Expandable Interbody System, is now available in the U.S. under a controlled market release. The device, which is used to treat degenerative disc disease, requires minimal implant insertion forces and allows for a customized fit. BeckersSpine.com (11/13)
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Government & Regulatory
Lawmaker: Repeal of medical device tax could come with Republican-led Congress
A good way to create jobs and stimulate the economy is to repeal the 2.3% medical device tax, and it's a move that has bipartisan appeal, writes Rep. Erik Paulsen, R-Minn. Paulsen sponsored a measure to repeal the tax that passed the House in September with the support of 32 Democrats. Although 79 senators indicated they would vote for repeal, the Democratic leadership in the Senate would not allow the issue to come to a vote. But that will change when the Republicans take over leadership of that chamber next year, Paulsen writes. The Wall Street Journal (tiered subscription model) (11/13)
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Industry exec commends proposed FDA oversight of LDTs
The FDA's proposed risk-based oversight of laboratory-developed tests would guarantee the effectiveness of the tests and safeguard patient safety, writes John Bishop, chairman and CEO of Cepheid and chairman of AdvaMedDx. Under the proposal, higher-risk LDTs would be subject to premarket reviews and a phase-in period of five years, while low-risk LDTs and tests for rare diseases would be exempted from similar regulatory requirements. The Hill/Congress Blog (11/12)
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AdvaMed News
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Editor's Note
A summary in AdvaMed SmartBrief on Wednesday should have said Lantheus Medical Imaging postponed its plans for an initial public offering in July. The company has announced it would pursue the IPO.
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In helping others, we shall help ourselves, for whatever good we give out completes the circle and comes back to us."
-- Flora Edwards,
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