ReCor Medical this week released “on-medication” results from the RADIANCE-HTN-SOLO clinical trial of its Paradise renal denervation system intended to treat uncontrolled hypertension, touting medication and blood pressure reductions at six months.
Results from the trial was presented at the American College of Cardiology’s 68th Annual Scientific Sessions in New Orleans and were simultaneously published in the journal Circulation.
Study investigators said that the six month “on-meds” results followed two month “off-meds” results that had been previously released after patients met their blood pressure primary outcomes. Patients in that trial remained blinded to treatment assignment and were put back on medications following a recommended, pre-set, stepped care, medical titration protocol.
“Professor Michel Azizi, my Co-PI for the RADIANCE-HTN study, the RADIANCE-HTN Steering Committee and I are very pleased to report the 6 month ‘on-meds’ results from the SOLO cohort of the study. These results are unique in that they represent blinded randomized data demonstrating that ultrasound renal denervation may have the potential to serve as an important adjunct to medications to lower blood pressure. We believe that in addition to the previously presented SOLO results in patients who were ‘off’ medications, these new data contribute to the growing body of evidence demonstrating that the Paradise System can lower blood pressure, either alone or in combination with anti-hypertensive medications. If confirmed in the larger and ongoing RADIANCE II trial, this therapy would have the potential to help patients and physicians reach their blood pressure goals – something that is frequently not achieved in clinical practice,” co-principal investigator Dr. Ajay Kirtane of Columbia University Irving Medical Center said in a prepared statement.
Results indicated that patients treated with the ReCor Paradise Ultrasound denervation system were prescribed fewer anti-hypertensive medications than those treated with a sham procedure, ReCor Medical said.
Treated patients also experienced greater blood pressure drops than those in the sham arm, with reductions maintained at six months and no reports of major adverse events.
“ReCor is encouraged by the SOLO 6 month outcome data as it is the first randomized, blinded, sham-controlled evidence of the effectiveness of the Paradise renal denervation system in combination with added anti-hypertensive medication. These data demonstrate the 6 month durability of the blood pressure lowering effect of the Paradise renal denervation system, either alone or in combination with medications. We are also excited that we have begun to randomize subjects in our RADIANCE-II pivotal study, which we plan to complete in 2020. The combination of our independent, blinded and sham-controlled RADIANCE-HTN SOLO and TRIO studies, the REQUIRE study being run in Japan and Korea, and our pivotal RADIANCE-II study will provide safety and efficacy outcomes on more than 600 patients, covering a broad range of patients with hypertension. If successful, we hope that, in the future, these studies may support an important new treatment option for millions of hypertensive patients worldwide,” CEO Andrew Weiss said in a press release.
HeartFlow this week presented results from the ADVANCE trial of its FFRct Analysis system, touting its ability to identify patients at low risk of cardiovascular events to reduce invasive testing.
Results from the trial were presented at the American College of Cardiology’s 68th Annual Scientific Sessions in New Orleans and simultaneously published in the Journal of the American College of Cardiology: Cardiovascular Imaging.
“These findings provide reassurance regarding the safety of patient management utilizing a FFRct-guided decision pathway, particularly in lower-risk patients who did not undergo an invasive evaluation. By adding the HeartFlow FFRct to our available resources for diagnosing stable coronary disease, we are able to provide patients with better care as we efficiently evaluate risk in patients getting a coronary CTA, more precisely stratify patients and improve efficiency in the cath lab,” Dr. Manesh Patel, of Duke University School of Medicine said in a prepared statement.
Study investigators in the more than 5,000-patient registry trial evaluated the use of FFRct values derived from the HeartFlow analysis to help determine patient’s risk of adverse cardiovascular events and for treatment planning. Patients in the trial underwent a coronary computed tomography angiogram with HeartFlow Analysis to follow when needed.
The majority of patients in the trial who received a negative HeartFlow Analysis received medical therapy and did not have to undergo invasive testing and treatment, HeartFlow said.
Study researchers reported a 0.2% rate of cardiovascular death or heart attack amongst the negatively-screened patients at one year, four times lower than patients who received a positive HeartFlow Analysis. Negatively-screened patients also had a low rate of revascularization through 90 days and negligible need for revascularization afterwards, the company said.
“The one-year results from ADVANCE are largely unchanged from the previously-presented 90-day results, which reinforces the durable utility of using coronary CTA as a front-line diagnostic test and incorporating the HeartFlow Analysis in a real-world patient population. By providing functional information, the HeartFlow Analysis is able to complement the anatomical information provided by a coronary CTA and enable the physician to have a more complete picture of the patient’s heart health, and thus provide more personalized care for the patient,” chief medical officer Dr. Campbell Rogers said in a prepared release.
AliveCor yesterday released data from three new studies of its KardiaMobile mobile electrocardiogram technology, touting its clinical utility and ability to streamline workflows.
Data from two trials were presented at the American College of Cardiology’s 68th Annual Scientific Sessions in New Orleans while another was published in Lancet’s EClinicalMedicine journal, Mountain View, Calif.-based AliveCor said.
Results from the EClinicalMedicine-published 243-patient trial performed at the University of Edinburgh and NHS Lothian indicated that ECGs taken with the KardiaMobile after discharge allowed doctors to diagnose 56% of patients in 9.5 days on average, higher than a 10% diagnosis rate and an average of 43 days reported with standard-of-care treatment. Data also indicated a cost-per-patient reduction of approximately $1,200, AliveCor said.
In one ACC 2019 presentation, AliveCor said that it touted the capabilities of its remote patient monitoring platform and its ability to integrate images from the KardiaPro mobile ECG into an EPIC electronic health records platform. The company also presented the latest version of the KardiaPro, which it says now supports reimbursement under the newest remote patient monitoring CPT codes.
The company also presented data on its KardiaMobile Gen 2 six-lead mobile ECG that is currently pending FDA 510(k) clearance, touting its ability to accurately measure the QT interval, which is associated with sudden cardiac death when prolonged. The company said that the system was trained off of data from over 200,000 Mayo Clinic patients to predict the QT interval.
AliveCor said that the QT prediction from the KardiaMobile Gen 2 ECG data was comparable to QT measured from a traditional 12-lead ECG.
“KardiaMobile is the most clinically validated mobile ECG in the world,” said Dr. Jacqueline Shreibati, Chief Medical Officer at AliveCor. “Every day, physicians and patients around the globe reaffirm AliveCor’s role in improving patient outcomes. AliveCor is proud to be involved in high-quality clinical research, including randomized controlled trials, and prospective validation studies of AI algorithms.”
Livongo late last week presented results from a study exploring the use of its Livongo for Hypertension solution’s ability to reduce blood pressure in patients with diabetes and uncontrolled high blood pressure.
Data from the trial was presented at the American College of Cardiology’s 68th Annual Scientific Sessions in New Orleans, the Mountain View, Calif.-based company said.
Livongo said that its Livongo for Hypertension solution includes a smartphone app for remote blood pressure monitoring, tips on healthy living and the ability to connect with a health coach.
Participants in the trial measured their blood pressure on average four times a week, with data automatically transmitted to Livongo’s Applied Health Signals platform, the company said.
Study researchers said that they recruited 708 individuals with diabetes and a starting blood pressure of greater than 130/80 mm HG for the trial, and that patients had an average reduction of 11.2 mm Hg for their systolic pressure and a decline of 5.2mm Hg to their diastolic pressure at six weeks.
“By giving our Members the opportunity to monitor their blood pressure readings at home and offering personalized insights and coaching to help them better understand their health, together we were able to drive meaningful behavior change that led to significant clinical outcomes at six weeks without the use of medication. This study effectively shows that by giving health consumers the tools they need to better manage their health, we can empower them to live healthier lives,” senior study author and chief medical officer Dr. Bimal Shah said in a prepared statement.
During the session, researchers explored the treatment of refractory angina in patients with no options, Vancouver-based Neovasc said, touting its Reducer’s ability to narrow the coronary sinus in refractory angina patients.
“We are pleased that today’s ACC.19 session included an overview of our Reducer and its efficiency in narrowing the coronary sinus in refractory angina patients, which has resulted in an improvement in symptoms and quality of life for patients with refractory angina who were not candidates for revascularization. A portion of the data discussed during the session was originally published in the New England Journal of Medicine in February 2015. Looking at the participants in this session, we see growing interest for the Reducer among leading cardiologists; Professor Thomas Luscher, who has treated patients with Reducer within his practice in Europe and co-authored a published paper on the Reducer, presented the Reducer data at ACC.19 and Dr. Tim Henry of Cedars-Sinai, who has been a strong supporter of generating additional data for the Reducer in the U.S., chaired the session,” CEO Fred Colen said in a press release.
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