A Digital Publication for the Practicing Medical Specialist, Industry Executive & Investor

No Carolina / New York

New Data Unveiled at Heart Rhythm 2020 Demonstrate Effectiveness of App-Based Remote Monitoring of Medtronic Cardiac Devices, Significant Reduction in Complications with Micra Leadless Pacemaker

May 8, 2020

During the current COVID-19 pandemic, procedures, and therapies that reduce exposure to other people are important because that also reduces the potential for spreading the virus. The results were presented at the annual Heart Rhythm Society Scientific Sessions, held virtually for the first time.

Results from the BlueSync™ Evaluation study demonstrated that patients who used the Medtronic MyCareLink Heart mobile app (MCLH), a remote monitoring application on a patient’s phone or tablet, were more likely to adhere to their pacemaker remote monitoring schedule than patients who used traditional bedside monitors.

The study found that patients using the MCLH technology successfully completed 94.6% of scheduled transmissions, which was superior to all three Medtronic bedside monitor control groups (whose results ranged from 56.3% to 87.1%).

Higher patient adherence to scheduled transmissions of remote monitoring suggests that patients who use the MCLH app are more likely to benefit from remote monitoring than those with low or no adherence to remote monitoring.

Numerous peer-reviewed, published studies have demonstrated the benefits of remote monitoring; it has been shown to:

  •  provide earlier detection and evaluation of patient clinical and device-related events1-4,
  •  reduce in-person clinic visits with no change in patient safety5-8,
  •  improve patient quality of life 9-11 and
  •  be associated with improved long-term patient survival12-14.

Medtronic introduced the world’s first remote cardiac monitoring system in 2002, and it has been embraced by two million patients worldwide. Because remote monitoring helps limit in-person contact between patients, caregivers, and physicians, it potentially reduces exposure to bacteria and viruses, including the virus that causes COVID-19.

“Remote monitoring for cardiac health is associated with better patient outcomes and is playing an important role in the care of patients during the COVID-19 pandemic as in-person clinic visits are restricted, ” said Rob Kowal, M.D., Ph.D., chief medical officer of the Cardiac Rhythm and Heart Failure division, which is part of the Cardiac and Vascular Group at Medtronic. “These findings are very promising for this first-of-its-kind technology, suggesting patients using this app-based approach are more likely to successfully transmit the important remote cardiac device data that physicians need to manage their patients.”

Micra TPS CED Study
Results from the Micra Coverage with Evidence Development (CED) Study showed that patients implanted with a Micra TPS experienced a 66% reduction in chronic complications at six months compared with patients who received a traditional transvenous VVI pacemaker (TV-VVI). These results provide the first insight into the real-world comparative effectiveness of Micra TPS in the Medicare population and represent the largest evaluation of leadless pacemakers to date.

“These results show that Micra’s lower likelihood of complications in earlier clinical trials is being maintained in real-world practice,” said Jonathan P. Piccini, M.D., associate professor of medicine and director of cardiac electrophysiology at Duke University Medical Center.

Approved by the FDA in 2016, the Micra TPS is the first and only leadless pacemaker option available globally. Micra does not require leads or a surgical “pocket” under the skin, so potential sources of complications related to leads and pockets are eliminated – which may reduce in-office or hospital visits, an important consideration during this pandemic.

FDA Approves Cobalt and Crome Portfolio

Medtronic has received FDA approval for its Cobalt™ and Crome™ implantable cardioverter-defibrillators (ICD) and cardiac resynchronization therapy-defibrillators (CRT-D), the first Medtronic “high power” devices to offer connected health, including the ability for clinicians to program devices from a physical distance, thereby reducing potential exposure to the virus that causes COVID-19. The devices use the MyCareLinkHeart mobile app, along with other exclusive features including:

  •  TriageHF Heart Failure Risk Status: TriageHF automatically provides patients’ heart failure risk assessments to clinicians and identifies changes that may lead to worsening heart failure. It evaluates multiple factors that can lead to hospitalization such as heart rate variability, atrial fibrillation and fluid status, and it is compatible with all Medtronic ICDs and CRT-Ds with the Medtronic OptiVol™ fluid status monitoring feature, including those currently implanted in patients.
  •  CareAlerts™: New CareAlert notifications help physicians manage clinically relevant events and direct their attention to patients who need it most, potentially before patients need in-office care. Clinicians can opt to receive CareAlerts via text, email and/or voicemail.
  •  Intrinsic ATP™: Intrinsic ATP (anti-tachycardia pacing) gives patients individualized therapy in real-time, with devices automatically adapting to a patient’s abnormally fast heart rhythms (ventricular tachycardia) and attempting to terminate them with painless pacing therapy, possibly avoiding the need for shocks and their associated hospitalizations.

About the Studies
The full recorded late-breaking presentations on the BlueSync Evaluation and Micra CED studies can be accessed at Heart Rhythm 365.

The BlueSync Field Evaluation was a prospective, multicenter study measuring the success rate of scheduled transmissions in pacemaker patients using the MCLH mobile app for 12 months. Scheduled transmission success was compared to 3 distinct groups of bedside monitor device users from the Medtronic de-identified CareLink™ database.

Compatible with Medtronic BlueSync technology-enabled cardiac devices, the MCLH mobile app is designed to securely and wirelessly send cardiac device data to the Medtronic CareLink™ network via a patient-owned phone or tablet, eliminating the need for a dedicated bedside monitor or other remote monitoring hardware.

The Micra Coverage with Evidence Development Study evaluated device performance in 5,746 Medicare patients implanted with a Micra TPS and 9,662 Medicare patients implanted with a traditional pacemaker (TV-VVI, regardless of manufacturer) using claims data from the Centers for Medicare & Medicaid Services.

Along with a significant reduction in complication rates, Micra TPS patients also had a reduction in the rate of device revision compared to patients implanted with a TV-VVI device. While event rates are low, cardiac effusion and/or perforation within 30 days was higher among Micra TPS patients than transvenous patients in both unadjusted and adjusted models (unadjusted, 0.8% vs. 0.4%, P<0.001; adjusted, 0.8% vs. 0.4%, P=0.002); however, results were consistent with findings from the Micra TPS investigational device exemption (IDE) study and post-approval registry.

In collaboration with leading clinicians, researchers, and scientists worldwide, Medtronic offers the broadest range of innovative medical technology for the interventional and surgical treatment of cardiovascular disease and cardiac arrhythmias. Medtronic strives to offer products and services of the highest quality that deliver clinical and economic value to healthcare consumers and providers around the world.


References:

1. Circ Arrhythm Electrophysiol. 2010;122:325-332.
2. J Am Coll Cardiol. 2011;57:1181-1189.
3. J Med Internet Res. 2013;15(8):e167
4. Circ Arrhythm Electrophysiol. 2010;3:428-436
5. Eur Heart J. 2014;35:98–105.
6. Circulation. 2010;122:325-332.
7. Eur Heart J. 2012;33:1105–1111.
8. Eur Heart J. 2013;34: 605–614
9. Eur Heart J. 2014;35:98–105.
10. Circulation. 2012;125:2985-2992.
11. Eur Heart J. 2012;33:1105–1111
12. Circulation. 2010;122:2359-2367
13. J Interv Card Electrophysiol. 2016:46(2):129-36
14. J Am Coll Cardiol. 2015;65:2601-2610.

Medical Device News Magazinehttps://infomeddnews.com
Medical Device News Magazine provides breaking medical device / biotechnology news. Our subscribers include medical specialists, device industry executives, investors, and other allied health professionals, as well as patients who are interested in researching various medical devices. We hope you find value in our easy-to-read publication and its overall objectives! Medical Device News Magazine is a division of PTM Healthcare Marketing, Inc. Pauline T. Mayer is the managing editor.

More News!

Dr. Michael Newman, Indaptus’ Founder, Chief Scientific Officer, and lead author, commented, “The new data are consistent with our preclinical animal tumor model studies and provide evidence for our hypothesis that patented Decoy bacteria can activate a wide range of innate and adaptive human immune cells involved in fighting tumors.  This aligns with what we’ve observed in our ongoing Phase 1 clinical trial of Decoy20 – broad immune activation, as evidenced by transiently increased levels of many key cytokines and chemokines following single dose administration. These findings bolster our confidence in Decoy20's potential as a multifaceted immunotherapy.”
To further understand the impact of platforms like TikTok on nutrition trends, MyFitnessPal partnered with Dublin City University on a research and experimental study that examined diet and nutrition content on TikTok. The study analyzed over 67,000 videos using Artificial Intelligence to compare them against public health and nutrition guidelines
Leveraging the power of Apple Vision Pro to seamlessly blend digital content with the physical world Osso Health brings the operating experience to life via detailed, clinically accurate workflows of common procedures.
“We are excited to present the first look at the safety and clinical activity of ELVN-001, which we believe supports the potential for ELVN-001 to address the limitations of the available active-site TKIs,” said Helen Collins, M.D., Chief Medical Officer of Enliven. “Across a wide dose range, ELVN-001 demonstrated activity in a heavily pre-treated patient population that includes post-asciminib patients, with a preliminary safety profile consistent with its highly selective design. Not only did all evaluable patients have improved or stable BCR::ABL1 transcript levels, but, importantly, 89% of all patients enrolled remain on study. We believe the initial data demonstrate the potential clinical utility of ELVN-001 for all types of patients, including those that are earlier in the treatment paradigm.”
The partnership is with Health-HavenRx ™, an online pharmacy platform. This partnership enables a new, convenient channel for patients to access POGO Automatic by using their health insurance on Intuity Medical’s e-commerce website at www.GoodtoPogo.com.

By using this website you agree to accept Medical Device News Magazine Privacy Policy