Medtronic's Renal Denervation Data Is a Major Turning Point

Medtronic's perseverance in renal denervation appears to be paying off – even if investors have "mostly given up" on the opportunity. Eight years after reporting unexpected results from the SYMPLICITY HTN-3 trial, the company presented promising three-year data from the first 80 patients in the SPYRAL HTN-ON MED trial at the American College of Cardiology's (ACC) 71st Annual Scientific Session that has renewed excitement around renal denervation. The data were also simultaneously published in The Lancet.

Abbott Scores FDA Approval for Its Leadless Pacemaker

Abbott's Aveir VR has become the second leadless pacemaker to reach the U.S. market. FDA approval for the new device came nearly six years ago to the day after FDA approved the Micra leadless pacemaker on April 6, 2016. Abbott's leadless pacemaker is equipped with a unique mapping capability designed to allow physicians to measure electrical signals within the heart and determine the correct placement of the device before final implantation. The Aveir VR also has an increased projected battery life and is designed to be retrieved if therapy needs evolve.

Dexcom's Savvy Business Move

 is getting ready to launch the Dexcom One in the United Kingdom in May. While it doesn't have all the bells and whistles that the G7 offers, the Dexcom One is intended to be a more affordable and accessible option for people with diabetes. It also represents a very intentional business move for Dexcom. The new continuous glucose monitoring system gives Dexcom a way to expand into geographies where it doesn't already have infrastructure or distribution partnerships in place, and where there may not be reimbursement or where reimbursement would be difficult. 

And in case you missed our last Medtech in a Minute report...

The Diabetes Company Everyone Is Talking About

There was quite a bit of buzz on Friday, April 1, about Embecta. The newly public diabetes company completed its separation from BD and began trading on the Nasdaq. MD+DI Managing Editor Omar Ford hosted the new company's CEO, Devdatt Kurdikar, on Let's Talk Medtech to discuss the spinout and what will give Embecta an edge in the diabetes tech market.

Medtronic's Latest Recall

Medtronic said it is recalling some of the In.Pact Admiral and In.Pact AV Paclitaxel-coated Percutaneous Transluminal Angioplasty balloon catheters because of manufacturing issues. The company said that some pouch damage was discovered during a routine inspection. Upon investigation, a change implemented to one manufacturing line was determined to be the cause. All batches manufactured on this line after that change are being retrieved. The problem on that line was fixed. Additionally, production on all lines was paused until a follow-up packaging inspection was completed. Medtronic said no further errors were discovered.

Supply Chain Issues Hamper Masimo in Q1

Citing shortages of critical components in combination with other supply chain issues, including freight carrier delays, the Irvine, CA-based medtech company said it now expects its product revenue for the first quarter to range from $285 million to $315 million. That is below analysts' consensus forecast of $330.1 million.