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Medtronic Reports Positive Harmony Transcatheter Pulmonary Valve Data

Medtronic Harmony transcatheter pulmonary valve

Medtronic Harmony transcatheter pulmonary valve

The Harmony transcatheter pulmonary valve. [Image courtesy of Medtronic]Medtronic (NYSE:MDT) announced positive two-year results for a study of its Harmony transcatheter pulmonary valve (TPV) system.

Harmony treats severe pulmonary regurgitation (PR) in the native or surgically repaired right ventricular outflow tract (RVOT). The Medtronic analysis demonstrates strong clinical and hemodynamic outcomes for patients with a congenital heart defect of the RVOT. The current standard of care is either open-heart surgery or other interventions early in life to address malformations. Harmony TVP provides a minimally invasive treatment alternative.

Medtronic presented results at the Society for Cardiovascular Angiography & Interventions (SCAI) 2023 Scientific Sessions.

"Sharing these longer-term outcomes for the Harmony transcatheter valve is an important milestone to help offer more streamlined treatment options for patients living with congenital heart disease," said Dr. Mary Hunt Martin, director of adult congenital intervention at the University of Utah and Primary Children's Hospital in Salt Lake City. "The strong safety profile reflected in these findings is especially encouraging since prior to Harmony, many of these patients would have to undergo multiple surgeries early on in their life."

The non-surgical heart valve first received FDA clearance in March 2021. However, in April 2022, FDA designated a Class I recall for the system. Medtronic recalled the system because of issues with the delivery catheter. The bond holding the capsule at the end of the delivery catheter could break during TPV placement, the company found.

Medtronic relaunched Harmony in February of this year.

The data supporting the Medtronic Harmony valve

Patients received a commercially available 22mm (TPV22) or 25mm (TPV25) Harmony valve as part of the Harmony Native Outflow Tract Early Feasibility Study (EFS), Harmony TPV Pivotal Trial, and Continued Access Study (CAS).

Eligible patients had severe PR by echocardiography or PR fraction greater than or equal to 30% by cardiac MRI and a clinical indication for pulmonary valve replacement. In the study, 86 patients received a TPV22 (42) or TPV 25 (44). All remained implanted for more than 24 hours.

Key findings included 0% vascular injury requiring intervention and 99% freedom from major stent fracture. Medtronic also reported 99% of patients with no/trace PR at two years.

"These findings help deepen our long-term evidence for Harmony TPV and underscore our commitment to providing solutions for congenital patients with complex anatomies," said Nina Goodheart, SVP and president of the Structural Heart & Aortic business at Medtronic. "Providing a system designed to reliably treat pulmonary regurgitation is an important way Medtronic innovations positively impacts this vulnerable patient population."


Echo Dot

As we have seen time and time again, not every device stores our sensitive data in a respectful manner. Some of them send our personal data out to third parties, even! Today's case is not a mythical one, however — it's a jellybean Amazon Echo Dot, and [Daniel B] shows how to make it spill your WiFi secrets with a bit of a hardware nudge.

There's been exploits for Amazon devices with the same CPU, so to save time, [Daniel] started by porting an old Amazon Fire exploit to the Echo Dot. This exploit requires tactically applying a piece of tin foil to a capacitor on the flash chip power rail, and it forces the Echo to surrender the contents of its entire filesystem, ripe for analysis. Immediately, [Daniel] found out that the Echo keeps your WiFi passwords in plain text, as well as API keys to some of the Amazon-tied services.

Found an old Echo Dot at a garage sale or on eBay? There might just be a WiFi password and a few API keys ripe for the taking, and who knows what other kinds of data it might hold. From Amazon service authentication keys to voice recognition models and maybe even voice recordings, it sounds like getting an Echo to spill your secrets isn't all that hard.

We've seen an Echo hijacked into an always-on microphone before, also through physical access in the same vein, so perhaps we all should take care to keep our Echoes in a secure spot. Luckily, adding a hardware mute switch to Amazon's popular surveillance device isn't all that hard. Though that won't keep your burned out smart bulbs from leaking your WiFi credentials.


Amazon Echo

As we have seen time and time again, not every device stores our sensitive data in a respectful manner. Some of them send our personal data out to third parties, even! Today's case is not a mythical one, however — it's a jellybean Amazon Echo Dot, and [Daniel B] shows how to make it spill your WiFi secrets with a bit of a hardware nudge.

There's been exploits for Amazon devices with the same CPU, so to save time, [Daniel] started by porting an old Amazon Fire exploit to the Echo Dot. This exploit requires tactically applying a piece of tin foil to a capacitor on the flash chip power rail, and it forces the Echo to surrender the contents of its entire filesystem, ripe for analysis. Immediately, [Daniel] found out that the Echo keeps your WiFi passwords in plain text, as well as API keys to some of the Amazon-tied services.

Found an old Echo Dot at a garage sale or on eBay? There might just be a WiFi password and a few API keys ripe for the taking, and who knows what other kinds of data it might hold. From Amazon service authentication keys to voice recognition models and maybe even voice recordings, it sounds like getting an Echo to spill your secrets isn't all that hard.

We've seen an Echo hijacked into an always-on microphone before, also through physical access in the same vein, so perhaps we all should take care to keep our Echoes in a secure spot. Luckily, adding a hardware mute switch to Amazon's popular surveillance device isn't all that hard. Though that won't keep your burned out smart bulbs from leaking your WiFi credentials.






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