States reportedly fend for themselves with inflated ventilator prices

The Puritan Bennett 560 (PB 560) ventilator [Image courtesy of Medtronic]

States had to scramble to obtain ventilators after the White House left them to fend for themselves, according to a Kaiser Health News report.

Demand for intensive care unit ventilators skyrocketed as healthcare facilities dealt with the surges of COVID-19 patients over the course of the pandemic, which still goes on today after gaining steam in March. Kaiser’s report noted that White House officials, such as senior adviser (and President Donald Trump’s son-in-law) Jared Kushner, claimed the federal stockpile was not meant for the states, leaving them to track down ventilators elsewhere.

As the Trump administration sought to replenish its own supply of ventilators, officials from a number of states have said that they ordered millions of dollars’ worth of machines from private companies, sometimes bidding against the fed…

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Blackstone invests $337m in Medtronic diabetes tech

Medtronic (NYSE:MDT) announced that it will increase research and development for its diabetes group through an agreement to receive $337 million from Blackstone.

The significant increase in R&D funding for the diabetes group is aimed at advancing new, innovative products designed to reduce the burden of diabetes management. The companies announced the agreement at the virtual 80th Scientific Sessions of the American Diabetes Association (ADA).

“This investment is important for people living with diabetes, as we expect it will expand our offering of future insulin delivery and sensor innovations that have the potential to improve patients’ management of their diabetes,” Medtronic executive VP & diabetes group president Sean Salmon said in a news release. “Over the past 12 months, Medtronic has significantly increased its investment in diabetes R&D, including investments in a series of near-term programs such as the MiniMed 780G insulin…

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Medtronic lands CE Mark for Micra AV transcatheter pacing system

Medtronic (NYSE:MDT) announced today that it received CE Mark approval in Europe for its Micra AV transcatheter pacing system (TPS).

The Fridley, Minn.-based medtech giant touts its Micra AV as the world’s smallest pacemaker with atrioventricular (AV) synchrony. The system is indicated for treating patients with AV block, adding to its CE Mark-approved leadless pacemaker portfolio.

Dr. José Ramón González Juanatey of the University Hospital in Santiago de Compostela, Spain, performed the first implants of Micra AV, according to a news release.

“This new device not only stimulates but is also able to recognize the electrical activity of the whole heart,” Juanetey said in the release. “Our ultimate goal is to bring the latest cardiovascular innovation to patients in our area. Now we can extend this wireless technology to other patients who require dual-chamber stimulation and in whom traditional stimulation cannot be p…

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Medtronic touts results of latest MiniMed studies at ADA

The latest generation of the Medtronic (NYSE:MDT) MiniMed insulin pump met both safety and glycemic endpoints in a study presented today at the American Diabetes Association’s virtual annual conference.

The MiniMed 780G closed-loop system is indicated for treating Type 1 diabetes in people aged 7 to 80 years old. It is designed to automate the delivery of both basal insulin and correction boluses every five minutes to help people with diabetes avoid highs and lows with greater ease, according to Fridley, Minn.-based Medtronic. It also enables patients to program insulin action time from two to eight hours, and has an adjustable target setting as low as 100 mg/dL. The MiniMed 780G won the CE Mark this week, but has not been approved for use in the U.S.

The 90-day at home U.S. pivotal trial included patients aged 14 to 75 years old and yielded no severe adverse events, according to the company. The trial results include:

No severe hypoglycemia and diab…
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Medtronic lands CE Mark for MiniMed 780G insulin pump

Medtronic (NYSE:MDT) announced today that it received CE Mark approval in Europe for its MiniMed 780G next-generation insulin pump.

The closed-loop insulin pump system is indicated for treating Type 1 diabetes in people aged 7 to 80 years old. It uses Medtronic’s SmartGuard algorithm to automate the delivery of basal insulin and correction boluses every five minutes.

The MiniMed 780G enables the personalization of glucose goals with an adjustable target setting as low as 100 mg/dL, which is lower than any other advanced hybrid closed-loop system, according to a news release.

Medtronic said patients who participated in a clinical study said the MiniMed 780G system “made life with diabetes and control so much easier.” Results from three trials using the system will be presented in a symposium at the virtual 80th Scientific Sessions of the American Diabetes Association.

The company expects to begin shipping the MiniMed…

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Medtronic StealthStation recall is Class I

The FDA announced that the recall of the Medtronic (NYSE:MDT) StealthStation deep brain stimulation (DBS) software is Class I, the most serious type of recall.

Initiated by Medtronic on Aug. 9, 2019, the recall includes the StealthStation auto-registration feature from its cranial software version 3.0 or newer with StealthStation DBS license or StealthStation S8 software with Stealth DBS License.

Devices impacted by the recall were distributed between Feb. 1, 2016, and May 1, 2019. According to the FDA release, 54 consignees were notified with affected products in the U.S. As of June 1, 2020, a total of 33 medical device reports were identified with 22 related to device malfunction and 11 related to injury.

Medtronic’s StealthStation DBS is used with the NexFrame Stereotactic system and O-arm imaging system to provide images of the brain, helping surgeons navigate tools and implants during a DBS procedure.

The auto-registration feature was r…

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Titan Medical announces $18m offering, settles Naglreiter suit

Titan Medical (TSX:TMD;OTC:TITFX) announced that it registered an $18 million direct offering and settled its lawsuit with Naglreiter Consulting.

The Toronto-based robot-assisted surgery technology developer entered into definitive agreements with a single healthcare-focused institutional investor for the sale of 18 million shares of its common stock at $1 per share and 9 million common share purchase warrants to net the gross proceeds of $18 million.

Titan intends to use the proceeds for general corporate purposes, including the resumption of the development of its single-port robotic surgical system, instruments and accessories. It also may go toward general working capital and capital expenditures.

According to a news release, the receipt of the proceeds will satisfy the second milestone requirement of its development and license agreement with Medtronic. H.C. Wainwright & Co. is acting as the exclusive placement agent for the offering.

In …

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Study: TAVR considered safe treatment for bicuspid valve disease

Medtronic Evolut R transcatheter aortic heart valve [Image from Medtronic]

A recent study has shown that transcatheter aortic valve replacement (TAVR) is a safe treatment option for people who need a bicuspid aortic valve replacement.

The study found that patients who were at an increased risk for surgery had a 30-day and one-year mortality rate and stroke rate similar to patients with more common tricuspid valves.

According to the researchers, 2% of the U.S. population has an aortic valve with two leaflets instead of three. The leaflets are supposed to open widely and close securely to regulate blood flow. Having bicuspid valves requires regular monitoring by physicians.

“No one’s valve works as well at age 70 as it does at age 20, but in patients with a bicuspid aortic valve, it’s more likely to wear out and require replacement,” the study’s lead author John Forrest …

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MedTech 100 roundup: Stocks stand pat in June’s first week

While the markets experienced some growth over the past week, stocks in the medtech industry remained practically unchanged over seven days.

MassDevice’s MedTech 100 Index — which includes stocks of the world’s largest medical device companies — sat at 87.15 points at the end of last week (June 5). That total represents just a -0.02-point decrease from the 87.17-point total at the same time a week prior (May 29), which represented the industry’s highest point since before the COVID-19 pandemic took hold of the markets.

Meanwhile, the S&P 500 Index experienced a 3.14% increase from May 29 to June 5 and the Dow Jones Index fared even better with a 6.81% increase over the same period of time. The market surge came on the back of the White House announcement that 2.5 million jobs were added in May and unemployment rose to 13.3% when a surge to nearly 20% was expected, according to Yahoo Finance.

The lowest point for medtech during the COVID-19 pand…

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Medtronic lands CE Mark for shorter therapy for high bleeding risk heart patients

Medtronic (NYSE:MDT) announced today that it received CE Mark approval for a one-month indication for high bleeding risk (HBR) patients implanted with the Resolute Onyx.

The medtech giant’s indication is for one-month dual antiplatelet therapy (DAPT) in HBR patients implanted with the Resolute Onyx drug-eluting stent (DES). In a news release, the company touted the indication as the first of its kind, allowing physicians to recommend a shorter regimen of DAPT after a percutaneous coronary intervention (PCI) with Resolute Onyx.

According to the release, Resolute Onyx is not currently indicated for HBR patients with one-month DAPT in the U.S., but data has been submitted to the FDA in an effort to obtain the indication. Medtronic said European approval followed its Onyx ONE global study, a one-month DAPT trial comparing Resolute Onyx to the Biosensors International (PINK:BSNRY) BioFreedom DCS.

Medtronic launched the 2,000-patient study in August 2017…

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Medtronic turns to Titan Medical as it makes robot-assisted surgery play

Titan Medical (TSX:TMD;OTC:TITFX) announced today that it entered into an agreement with Medtronic (NYSE:MDT) to progress the development of robot-assisted surgical technologies.

The development and license agreement to develop those technologies is accompanied by a separate license agreement with Medtronic in respect of certain intellectual property of Titan Medical, according to a news release.

Under the agreement, both companies can develop robot-assisted surgical systems in their respective businesses, while Titan will receive a series of payments that reach $31 million in return for Medtronic’s license for the technologies. The payments will arrive as milestones are completed and verified.

A steering committee made up of representatives from each company will be established to oversee the milestones, one of which is Titan’s task to raise an additional $18 million in capital within four months of the development start date that is expecte…

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U of M releases Coventor ventilator design as open-source

The University of Minnesota recently announced that it released the design for its Coventor alternative ventilator as open-source.

Minnesota’s Coventor low-cost device gained notoriety in March after researchers touted the design made from various parts totaling just $150. In April, it became the first ventilator of its kind authorized for use under the FDA’s EUA for the COVID-19 pandemic.

Also in April, Boston Scientific (NYSE:BSX) announced that it was sole manufacturer of the device, which the company said it expects to sell at-cost at approximately $1,000 per unit.

The Coventor is now available to companies who are interested in manufacturing it. They can sign a free electronic license and download the manufacturing specifications.

“From the outset, the mission of this project was to make this emergency device available to people in need, wherever they might be in the world, as quickly and safely as possible,” Dr. Stephen Richardson, a…

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