renal denervation Archives - Page 3 of 4

What’s next for Medtronic RDN after Symplicity Spyral trial ‘surprise’?

The Symplicity Spyral renal denervation system delivers energy to the nerves leading to the kidneys, which help regulate blood pressure. [Image courtesy of Medtronic]

The Medtronic (NYSE:MDT) Symplicity Spyral renal denervation (RDN) treatment’s failure to outperform hypertension drugs came as unexpected news to analysts who have been watching the industry’s efforts in the space for years.

Analysts from BTIG and Truist Securities said they have new questions about commercialization, reimbursement and physician acceptance as Medtronic seeks FDA approval for what could be a billion-dollar business.

While the Symplicity Spyral treatment for patients on blood pressure medication was demonstrated to be safe and showed a statistically significant and clinically meaningful reduction in office-based systolic blood pressure, the treatment failed to meet its primary efficacy endpoint.

“The…

Medtronic RDN trial fails to beat hypertension drugs; data submitted for FDA review

Medtronic’s Symplicity Spyral renal denervation catheter [Image courtesy of Medtronic]Medtronic (NYSE:MDT) said its Symplicity Spyral renal denervation (RDN) system for treating hypertension failed to outperform blood pressure drugs in the latest trial results.

However, the SPYRAL HTN-ON MED clinical trial’s six-month results did show improvement over Medtronic’s previous RDN efforts, the device maker said in a news release.

RDN is designed to treat hypertension with a one-time outpatient procedure that delivers energy to the nerves in the wall of the artery leading to the kidney. Medtronic’s Symplicity Spyral catheter device delivers radiofrequency energy through four electrodes.

RELATED: What is renal denervation? Medtronic Coronary and RDN President Jason Weidman explains

Medtronic said it submitted the final module of the Symplicity Spyral Premarket Approval package to the FDA for review and approval.

The company pr…

4 major cardiology trends you need to know from TCT 2022

Medtronic, Edwards and Abbott presented positive data as TAVR, TEER and renal denervation innovations continue to arrive.

The 34th Transcatheter Cardiovascular Therapeutics (TCT) conference took place in Boston this past week and a ton of big names made waves with their technologies and innovations.

Medtronic, Abbott, Edwards and Boston Scientific represent a few of the companies revealing new data for their cardiovascular offerings. ReCor Medical, Abiomed and more got involved, too.

Plenty of the study outcomes represented positive steps forward, while other companies hit speed bumps in their efforts. Here are some of the biggest takeaways from the conference:

1. Renal denervation innovations plug along

Medtronic (NYSE:MDT) announced study data that demonstrates significant blood pressure reduction with the Symplicity renal denervation system.

The RDN minimally invasive procedure delivers radiofrequency energy to specific nerves near the …

Medtronic’s renal denervation system demonstrates better blood pressure control, time in range

The Symplicity Spyral renal denervation system delivers energy to the nerves leading to the kidneys, which help regulate blood pressure. [Image courtesy of Medtronic]Medtronic (NYSE:MDT) announced today that new data supports the use of its Symplicity Spyral renal denervation (RDN) system.

As part of the medtech giant’s Spyral HTN global clinical program, three-year data from the Spyral HTN-ON MED and GSR-Define trials were presented at EuroPCR 2022 as late-breaking clinical trials demonstrating the benefit of the Symplicity blood pressure procedure with Simplicity Spyral.

The Medtronic RDN minimally invasive procedure delivers radiofrequency energy to specific nerves near the kidneys that can become overactive and cause high blood pressure. It is currently limited to investigational use in the United States, Japan and Canada.

Results from the first 80 patients in the Spyral HTN-ON MED trial show improved blood pressure control with significantly high…

Medtronic releases new renal denervation results, closes trial enrollment

The Symplicity Spyral renal denervation system delivers energy to the nerves leading to the kidneys, which help regulate blood pressure. [Image courtesy of Medtronic]Medtronic (NYSE:MDT) today said its Symplicity Spyral renal denervation (RDN) system demonstrated durable, clinically significant blood pressure reductions through three years for patients on medication.

It’s the latest development out of Medtronic’s Spyral HTN-ON MED trial testing the company’s RDN catheter system, which delivers radiofrequency energy to overactive nerves near the kidneys that cause high blood pressure. Medtronic released the results in The Lancet and at the American College of Cardiology’s 71st Annual Scientific Session.

“For the first time, we now have randomized data that demonstrates that in a typical patient population — hypertension patients who are on anti-hypertensive medications and treated with RDN — we are seeing the continued, long-term blood pressure lowering effect,” Dr…

Medtronic releases new renal denervation results, closes trial enrollment

The Symplicity Spyral renal denervation system delivers energy to the nerves leading to the kidneys, which help regulate blood pressure. [Image courtesy of Medtronic]

Medtronic (NYSE:MDT) today said its Symplicity Spyral renal denervation (RDN) system demonstrated durable, clinically significant blood pressure reductions through three years for patients on medication.

It’s the latest development out of Medtronic’s Spyral HTN-ON MED trial testing the company’s RDN catheter system, which delivers radiofrequency energy to overactive nerves near the kidneys that cause high blood pressure. Medtronic released the results in The Lancet and at the American College of Cardiology’s 71st Annual Scientific Session.

“For the first time, we now have randomized data that demonstrates that in a typical patient population — hypertension patients who are on anti-hypertensive medications and t…

Some analysts are upbeat about Medtronic’s renal denervation prospects

The Symplicity Spyral renal denervation system delivers energy to the nerves leading to the kidneys, which help regulate blood pressure. [Image courtesy of Medtronic]

Needham & Co. analysts are reiterating their Buy rating for Medtronic stock, saying that renal denervation (RDN) could still be a big opportunity for the medtech giant.

Medtronic (NYSE:MDT) had to continue its Spyral HTN-ON MED trial into this year after failing to obtain the positive results needed to end enrollment early for the potential hypertension treatment.

During Medtronic’s Q3 earnings call in February, CEO Geoff Martha said the company expects to complete the six-month follow-up to ON MED in the second half of this calendar year. It’s the final piece of information Medtronic needs to submit for FDA approval of its Symplicity Spyral device.

Medtronic’s Symplicity Spyral device delivers energy to the ner…

Some analysts are upbeat about Medtronic’s renal denervation prospects

The Symplicity Spyral renal denervation system delivers energy to the nerves leading to the kidneys, which help regulate blood pressure. [Image courtesy of Medtronic]Needham & Co. analysts are reiterating their Buy rating for Medtronic stock, saying that renal denervation could still be a big opportunity for the medtech giant.

Medtronic (NYSE:MDT) had to continue its Spyral HTN-ON MED trial into this year after failing to obtain the positive results needed to end enrollment early for the potential hypertension treatment.

During the company’s Q3 earnings call in February, CEO Geoff Martha said that the company expects to complete the six-month follow-up to ON MED in the second half of this calendar year. It’s the final piece of information Medtronic needs to submit for FDA approval of its Symplicity Spyral device.

Medtronic’s Symplicity Spyral device delivers energy to the nerves in the wall of the artery leading to the kidney during a …

MedtronicTalks: Why Symplicity Spyral trials are complicated, but worth it

Medtronic’s campaign to secure FDA approval – Symplicity Spyral – has been anything but simple.

But in this episode of the MedtronicTalks podcast, Jason Weidman, senior vice president and president of Coronary & Renal Denervation, explains why the company has refused to give up the fight to develop the renal denervation tool to lower hypertension.

Weidman explains why the company couldn’t share updated clinical data this fall as it hoped and he gives a new timeframe for the next milestone.

MedtronicTalks · Weidman walks the long road to get Symplicity Spiral ready to help patients with hypertension

What is renal denervation? Medtronic Coronary and RDN President Jason Weidman explains

Jason Weidman is a Medtronic SVP and president of its coronary and renal denervation business. [Photo courtesy of Medtronic]

As Medtronic (NYSE:MDT) continues clinical trials of its Symplicity Spyral renal denervation (RDN) system for treating hypertension, the Fridley, Minnesota-based medical device maker now hopes to win FDA approval in 2023.

To better understand the technology behind what Medtronic leaders expect to become a multibillion-dollar business, Medical Design & Outsourcing spoke with Jason Weidman, Medtronic senior vice president and president of the coronary and renal denervation business, which is part of Medtronic’s cardiovascular portfolio. (We’ve edited this conversation for brevity and clarity.)

MDO: What’s the simplest way to explain renal denervation?

Weidman: The basic idea is that your kidneys are part of the body’s blood pressure control mechanis…

Medtronic faces longer road to renal denervation

The Symplicity Spyral renal denervation system delivers energy to the nerves leading to the kidneys, which help regulate blood pressure. [Image courtesy of Medtronic]

Medtronic (NYSE:MDT) will continue the Spyral clinical study of its Symplicity renal denervation (RDN) system for hypertension into next year after lacking the positive results needed to end enrollment early.

Fridley, Minnesota-based Medtronic said last month that it hoped to present results of the Spyral HTN-ON MED trial at the Cardiovascular Research Foundation’s TCT Conference in early November, pending an interim analysis in October.

Significantly positive results would have advanced Medtronic’s efforts for FDA approval. But the independent data safety monitoring board conducting that analysis — meant to end trial enrollment if results are significantly better or worse than expected — recommended that Medtronic continue enro…

Medtronic builds suspense for renal denervation study results

The Symplicity Spyral renal denervation system delivers energy to the nerves leading to the kidneys, which help regulate blood pressure. [Image courtesy of Medtronic]Medtronic’s clinical study of its Symplicity Spyral renal denervation system for hypertension is likely to go down to the wire for inclusion as a late-breaking clinical trial at the upcoming Transcatheter Cardiovascular Therapeutics (TCT) conference.

The highly anticipated results will offer new insight into the Fridley, Minnesota-based medical device manufacturer’s quest to build a billion-dollar business treating hypertension. CEO Geoff Martha recently reported “good progress” in those efforts, saying the trial “represents the final piece of a large body of evidence that we intend to submit to the FDA for approval.”

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