Medtronic Archives - Page 58 of 59 - Medical Design Sourcing

Medtronic is making its ‘artificial lung’ therapy available for COVID-19 treatment

The Medtronic Affinity CP centrifugal blood pump [Image courtesy of Medtronic]

Medtronic (NYSE:MDT) is temporarily modifying product indications so that health providers can use its extracorporeal membrane oxygenation (ECMO) technology to treat people with severe cases of COVID-19.

ECMO could be described as a type of “artificial lung” technology that pumps blood from a person’s body to an oxygenator that provides long-term oxygen and carbon-dioxide transfer. Medtronic has devices that are FDA-cleared for extracorporeal support of up to 6 hours — an appropriate amount of time for cardiopulmonary bypass procedures (up to 6 hours).

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Medtronic is making its ‘artificial lung’ therapy available for COVID-19 treatment

The Medtronic Affinity CP centrifugal blood pump [Image courtesy of Medtronic]

Medtronic (NYSE:MDT) is temporarily modifying product indications so that health providers can use its extracorporeal membrane oxygenation (ECMO) technology to treat people with severe cases of COVID-19.

ECMO could be described as a type of “artificial lung” technology that pumps blood from a person’s body to an oxygenator that provides long-term oxygen and carbon-dioxide transfer. Medtronic has devices that are FDA-cleared for extracorporeal support of up to 6 hours — an appropriate amount of time for cardiopulmonary bypass procedures (up to 6 hours).

In accordance with a new FDA guidance, Medtronic says the following devices can now be used for longer than 6 hours in an ECMO circuit to treat people experiencing acute respiratory/cardiopulmonary failure during the COVID-19 pandemic:

The Bio-Console 560…

Medtronic recall of DBS placement software is Class I

FDA said today that a Medtronic (NYSE:MDT) recall of software used to help place deep brain stimulation systems is Class I, the agency’s most serious level.

The company in August 2019 recalled the auto-registration feature of its StealthStation DBS software due to inaccuracies caused by minor patient movements during the auto-registration process when used with NexFrame stereotactic system during a DBS procedure. The problem — which may not be detected by the surgeon or the device system — resulted in 11 reports related to injuries and another 22 related to malfunctions, according to FDA.

Medtronic’s Urgent Medical Device Correction letters advised health providers to weigh the benefits versus risks of fiducial-based or fiducial-less registration methods, providing additional instructions to ensure navigational accuracy during a procedure.

The recall specifically involves the Medtronic StealthStation auto-registration feature from the cranial…

FDA labels Medtronic HeartWare HVAD Pump Outflow Graft recall as Class I

Medtronic (NYSE:MDT) issued a Class I recall of its HeartWare HVAD Pump Outflow Graft and Outflow Graft Strain Relief.

The company said the outflow graft of the HVAD Pump could tear and the strain relief screw may break during assembly prior to implant, but might not be observed until during or after the pre-implant pump assembly and attachment to the HVAD pump.

Medtronic said using the affected products could result in serious patient harm, including dizziness, loss of consciousness, bleeding, fluid buildup around the heart, additional medical procedures and death, according to the recall.

So far, the company has received 92 complaints related to the device.

Medtronic has sent an Important medical Device Safety Alert to all affected customers. The company recommends reviewing the steps listed in the device’s appendix for assembly and attachment, closely inspecting the graft after assembly and before implantation, practicing standard peri-op…

Poll: Patients want to return to the doctor

AdvaMed said polling data confirmed that nearly half of American adults surveyed said they or someone in their household postponed or skipped medical care as a result of COVID-19.

The poll, released yesterday by the Kaiser Family Foundation showed that 48% of those adults or adults in their household had to put off medical care during the pandemic. It also revealed that 68% of those who postponed care expect to receive that care in the next three months, while 11% of respondents reported worsened health as a result of the delay in care.

“We already knew that too many patients have been going without the care that is absolutely vital to their health, and what this poll confirms is that patients themselves are anxious and ready to continue the care that was put on pause because of COVID-19,” AdvaMed president & CEO Scott Whitaker said in a news release. “It’s time for these essential medical procedures to resume. Last week, we joined AORN and AHA in releasing…

Report: New Medtronic CEO challenges Trump on ‘reshoring’

Geoff Martha, CEO of Medtronic

New Medtronic (NYSE:MDT) CEO Geoff Martha openly disagreed yesterday with President Donald Trump’s mission to bring formerly U.S.-based companies back to this country, according to a report in the Irish Times.

Medtronic, which maintains a U.S. headquarters in Fridley, Minn., bought Dublin-based Covidien for $50 billion in 2015 and moved its global headquarters to Ireland in a move critics cast as an attempt to avoid higher U.S. taxes. In the wake of distribution and supply chain disruptions caused by the coronavirus pandemic, Trump has been calling for formerly U.S.-based companies to come home.

Martha said such “reshoring” is not the answer, according to the Irish Times article. “We all recognize that supply chains are globalized,” Martha told the newspaper. “It is not just where you manufacture. Take our ventilators which we make in Galway, for exampl…

15 heart devices that could boost their manufacturers’ sales

(Image from Cardiovalve)

Before the coronavirus pandemic hit, medtech companies large and small were making notable news with a number of innovative heart devices.

Some of these same companies took a big hit to their bottom lines when the danger of spreading COVID-19 and using up precious personal protective equipment convinced hospitals to limit non-urgent procedures.

Now hospitals are looking at ways to safely return to business-as-usual — they and the medical device industry as a whole hope to improve their balance sheets. For example, Medtronic (NYSE:MDT) CEO Geoff Martha and CFO Karen Parkhill expressed optimism in an analyst call today that their company’s businesses already are showing signs of a rebound in the month of May.

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Medtronic execs see quick recovery, increased M&A

Medtronic CEO Geoff Martha

If Medtronic’s troubling Q4 report offers a snapshot of a company hit hard by COVID-19, the next image in the sequence may show a faster-than-expected recovery and increased merger-and-acquisition of smaller companies.

In the quarterly call on Thursday morning, Medtronic CEO Geoff Martha and CFO Karen Parkhill expressed optimism that the company’s businesses already are showing signs of a rebound in the month of May.

At the same time, Medtronic executives believe the broader financial pressures on the industry will create attractive opportunities to acquire companies that will add to its growth rate.

Get the full story at our sister site, MassDevice.

Medtronic execs see quick recovery, increased M&A

Geoff Martha, CEO of Medtronic

If Medtronic’s troubling Q4 report offers a snapshot of a company hit hard by COVID-19, the next image in the sequence may show a faster-than-expected recovery and increased merger-and-acquisition of smaller companies.

In the quarterly call on Thursday morning, Medtronic CEO Geoff Martha and CFO Karen Parkhill expressed optimism that the company’s businesses already are showing signs of a rebound in the month of May.

At the same time, Medtronic executives believe the broader financial pressures on the industry will create attractive opportunities to acquire companies that will add to its growth rate.

Martha said he expects recovery in the Northeast United States will lag behind other regions because the “fear factor is higher.” But other regions are moving forward. “We are seeing early signs of the recovery,” he said. “Maybe it’s too early to extrapolate throughou…

Medtronic misses mark in Q4 as sales decline 26%

Medtronic (NYSE:MDT) announced fourth-quarter results today that were even worse than expected, but the world’s largest medical device company is still upping its dividend and investing in future growth.

The Fridley, Minn.–based medtech giant reported profits of $646 million, or $0.48 per share, on sales of $6.0 billion for the three months ended April 24, 2020, for a bottom-line slide of 46% on a sales decline of 26% compared with Q4 2019.

Adjusted to exclude one-time items, earnings per share were 58¢, 48¢ behind The Street, where analysts were looking EPS of $1.06 on sales of $7.02 billion.

Because Medtronic’s previous quarter unlike many other medical device companies finished at the end of April versus the end of March, the results out today are some of the first to truly reflect the economic devastation wrought by the COVID-19 pandemic. Medtronic had already warned that its weekly revenue was down 60% in April as hospitals ended electiv…

Medtronic appoints new VP & CMO for coronary, renal denervation & structural heart

Medtronic (NYSE:MDT) announced that it appointed Dr. Jeffrey Popma as its new VP and chief medical officer for coronary, renal denervation and structural heart business.

Popma, a professor of medicine at Harvard Medical School and director of interventional cardiology at Beth Israel Deaconess Medical Center in Boston, is slated to provide medical leadership across those businesses, serve as a strategic advisor for cardiovascular device innovation and help to develop a clinical research portfolio, according to a news release.

He is set to assume the role on June 22 and report to Nina Goodheart, president of the coronary & structural heart division as part of the cardiac and vascular group.

“I am honored to be joining Medtronic to help deliver on its enduring Mission of patient-focused medical device innovation,” Popma said in the release. “I look forward to collaborating with the talented cardiovascular and structural heart teams at Medtro…

Medtronic touts positive results for Melody TPV, Harmony TPV

Medtronic (NYSE:MDT) today announced the results of two successful clinical trials for its Melody transcatheter pulmonary valve (TPV) therapy.

The Fridley, Minn.-based medtech giant virtually presented its 10-year outcomes at the 2020 Society for Cardiovascular Angiography & Interventions (SCAI) scientific sessions. Melody demonstrated strong long-term hemodynamic and safety outcomes, while the investigational Harmony TPV pivotal trial met safety and efficacy endpoints for hemodynamic function at six months, according to a news release.

Melody TPV demonstrated consistent hemodynamics through 10 years with strong valve efficacy with 97% none/trace/mild pulmonary regurgitation. Annualized incidence of TPV-related endocarditis was 2% per patient-year, while freedom from major stent fracture came in at 84% at 10 years and freedom from reintervention was 61%.

That study included 150 implanted patients between age 7 and age 53, with a median age of 19 and …