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
The RDN minimally invasive procedure delivers radiofrequency energy to specific nerves near the kidneys that can become overactive and cause high blood pressure. Results from the SYMPLICITY HTN-3 trial demonstrated a statistically significant reduction in office and ambulatory blood pressure compared to a sham control group.
Questions arose last year when Medtronic announced that it had to continue its pivotal Spyral HTN-ON MED trial into this year. The trial failed to produce the positive results needed to end enrollment early for the potential hypertension treatment. However, analysts have remained bullish on Medtronic’s RDN treatment.
Medtronic plans to present Spyral HTN-ON MED results at the American Heart Association Scientific Sessions this November. Spyral HTN-ON MED is the final piece of Medtronic’s FDA submission for Symplicity Spyral.
In other renal denervation news, a trial for ReCor Medical’s Paradise ultrasound renal denervation (uRDN) treatment met its primary efficacy endpoint.
ReCor’s CEO said the data is “further evidence that the Paradise uRDN System lowers blood pressure in a wide range of patients who are struggling to control their hypertension.” (ReCor Medical is part of Otsuka Holdings’ Otsuka Medical Devices subsidiary.)
2. TEER therapy competition heats up
The CLASP IID pitted the Pascal device from Edwards Lifesciences (NYSE:EW) against the MitraClip from Abbott (NYSE:ABT). Edwards presented data just days after the FDA approved the Pascal system for transcatheter edge-to-edge repair (TEER) in patients with degenerative mitral regurgitation (DMR).
Data from CLASP IID confirmed that TEER therapy is both safe and effective. The trial met its primary safety and effectiveness endpoints, according to a news release. Pascal also demonstrated non-inferiority for safety and effectiveness compared to MitraClip.
“As one physician panelist put it, ‘It’s been a good day for TEER therapy,’” BTIG analyst Marie Thibault says. “We view CLASP IID as a clear success in showing PASCAL is safe, effective and commercially viable.”
Thibault added that physicians at TCT cautioned against the direct comparison between the Edwards and Abbott devices. Despite the data’s slight skew toward Pascal, Abbott still presented positive data on its MitraClip system.
Data from more than 1,000 patients confirm that MitraClip offers high success rates in terms of MR reduction. It also demonstrated improvements in quality of life and low adverse event rates.
“MitraClip provides long-term, significant mitral regurgitation reduction that changes and saves lives,” said Michael Dale, SVP of Abbott’s structural heart business.
3. TAVR studies see mixed results
Medtronic kicked off TCT by announcing the full U.S. launch of its next-generation Evolut FX transcatheter aortic valve repair (TAVR) system. It went on to present positive data from multiple trials supporting its transcatheter heart valve replacement devices.
The Pathological Study of Hypo-Attenuated Leaflet Thickening (HALT) represents part of the CoreValve and Evolut TAVR program. It compares microCT and histology findings of valve leaflet thickening. Medtronic said in a news release that the trial is the first to compare such things. It may provide clinical insights into the long-term durability of transcatheter aortic valves (TAVs) and the treatment of HALT.
“As TAVR continues to grow as a treatment option for aortic stenosis, identifying pathological changes to TAVs over time is critical for understanding their long-term durability,” said Nina Goodheart, SVP and president of the Structural Heart & Aortic business at Medtronic.
Elsewhere at TCT, Boston Scientific’s TAVR-related study failed to meet its primary endpoint.
Boston Scientific designed the Sentinel cerebral protection system to capture and remove embolic debris stemming from TAVR. The aim is to extract the debris before it can reach the brain, potentially causing a stroke. Sentinel provides cerebral embolic protection (CEP) during TAVR.
Data from the PROTECTED TAVR trial demonstrated a non-significant trend toward a lower rate of stroke in patients treated with Sentinel. Despite the missed endpoint, a secondary analysis of Sentinel demonstrated a statistically significant 60% relative risk reduction in disabling stroke through 72 hours or time of hospital discharge.
Thibault said a physician panel at TCT still voted 7 to 1 in favor of using Sentinel when polled publicly. Dr. Ian Meredith, global CMO, Boston Scientific, said the company believes the data shows that Sentinel represents “an effective therapy to reduce the risk of the most debilitating form of stroke for patients undergoing TAVR.”
4. In the LAA closure fight, Amplatzer Amulet takes the latest round
Abbott and Boston Scientific’s left atrial appendage (LAA) closure devices went head-to-head again. This time, Abbott came out on top.
The company reported that device-related factors and all-cause death represented categories favoring its Amplatzer Amulet against Boston Scientific’s Watchman.
Abbott reported three-year outcomes for the Amulet IDE trial. It found that device-related thrombosis or peri-device leak more frequently preceded strokes in patients with Watchman compared to those with Amulet. The company said cardiovascular and all-cause death trended higher in the Watchman device than in the Amulet device.
Data from last year’s TCT demonstrated that Boston Scientific’s next-generation Watchman FLX stroke prevention device outperformed the Amulet device. Findings from the SEAL FLX study found that Watchman FLX demonstrated superiority in the area of LAA closure and peri-device leak.
The battle between the two devices continues to be one to watch.