12 Jun 2019

VECLOSE EXTENSION STUDY: Five-year outcomes prove durability, safety, efficacy of VenaSeal Closure System

    By Larry Storer Five-year results from the 2019 VeClose Extension Study of the Medtronic VenaSeal Closure System demonstrate that the treatment modality is consistent, durable and safe for permanently closing veins in patients with venous reflux disease. When compared with Medtronic Radiofrequency Ablation, VenaSeal continued to show “non-inferiority”

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21 May 2019

HIDDEN FDA REPORTS MASKED THE SCOPE OF WIDESPREAD HARM FROM FAULTY HEART DEVICE

By Christina Jewett Faced with the possibility that a bout of abnormal heartbeats could end his life, in 2006, Dr. Marc Sicklick had a small device implanted in his chest that would shock it back into rhythm. Soon he would struggle with another life-or-death choice: whether to remove the Sprint Fidelis,

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09 May 2019

Government policy shift prompts Medtronic to bail on bundled knees; Responsive Orthopedics for sale

After three years in the bundled joint replacement business, a federal policy shift is prompting Medtronic to put its Responsive Orthopedics business on the auction block. The May 2016 acquisition of Minneapolis-based Responsive for an undisclosed amount put Medtronic in line for a bundled joint replacement program piloted by the Centers for Medicare & Medicaid Services. The 5-year “Comprehensive

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28 Mar 2019

A NEW RF SYSTEM: VENCLOSE 2ND GENERATION RADIOFREQUENCY TECHNOLOGY OUTPERFORMS LEGACY SYSTEM

    By Larry Storer The great medical technology companies of our time start and develop in a variety of ways. Some start with a product or idea and built a market around it. Some start as spinoffs from existing successful companies. But Venclose started by determining the unmet needs

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28 Mar 2019

FDA evaluating stents, balloons with paclitaxel coating following JAHA evaluation

A December study in The Journal of the American Heart Association by Konstantinos Katsanos, MD, of Rion, Greece, et al, reported a higher risk of death after balloons and stents used to open vessels in the legs were coated with an anti-inflammatory chemo agent called paclitaxel. “Further investigations are urgently

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28 Mar 2019

Judge accepts Medtronic plea settling ev3 case

A federal judge in Boston accepted a plea deal from Medtronic neurovascular subsidiary ev3 in an off-label marketing case, according to court documents released at the end of January. U.S. Magistrate Judge Judith Dein granted the motion, which included the forfeiture of $6 million and an additional $11.9 million in

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14 Jan 2019

MEDTRONIC SETTLES DOJ CLAIMS LODGED AGAINST ACQUIRED FIRMS FOR $50.9M

  Medtronic has agreed to pay the U.S. Department of Justice $50.9 million to resolve three claims against Covidien and ev3, two companies Medtronic acquired in 2015. One payment is for $13 million and settles the DOJ’s investigation of the STRATIS Registry, which was designed to assess clinical outcomes of Covidien’s

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07 Jan 2019

MEDTRONIC GETS OK TO STUDY PATIENTS WITH BICUSPID AORTIC VALUES USING COREVALVE EVOLUT TAVR SYSTEM

The U.S. Food and Drug Administration (FDA) has approved an investigational device exemption (IDE) for Medtronic to initiate a single-arm study to evaluate the CoreValve Evolut TAVR system in patients with bicuspid aortic valves who are at low risk of surgical mortality. Medtronic separately received FDA approval for revised commercial

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03 Jan 2019

IN.PACT ADMIRAL:  MEDTRONIC SHARES FIVE-YEAR DRUG-COATED BALLOON DATA

  Medtronic plc data presented Nov. 12 reinforce the durability, safety, and effectiveness of the IN.PACT Admiral drug-coated balloon (DCB) in patients with peripheral artery disease in the superficial femoral and popliteal arteries. The five-year and final results from the pivotal IN.PACT SFA Trial and one-year all-subjects results from the

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12 Oct 2018

CYBER ATTACK FEAR LEADS TO MEDTRONIC DISABLING PACEMAKER INTERNET UPDATE

  Medtronic has disabled the internet update functionality of two of its CareLink devices used to program pacemaker implants amid concerns that they may be susceptible to cyberattacks, according to a letter from the medtech giant to healthcare professionals. Vulnerabilities had been identified in the update download process that could allow an individual

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