Impulse Dynamics – the company for which I am CTO and Executive VP – announced today that it received European approval for labeling the OPTIMIZER Smart IPG as MR-Compliant for full-body MRI scans utilizing 1.5 Tesla scanners:
Berlin Heals just published the results of its first-in-human study of its C-MIC device, which was conducted in 10 NYHA Class III heart failure patients with LVEF<35%. The C-MIC is an implantable electroceutical device intended to readjust the disturbed myocardial electrical gradient that, according to Berlin Heals, occurs in heart failure patients.
In the study follow‐ups, a rapid and significant signal of efficacy (P < 0.005) was present with improvements in LVEF, left ventricular end‐diastolic diameter, left ventricular end‐systolic diameter, and distance walked. For eight patients, NYHA classification improved from Class III to Class I (for seven, as early as 14 days post‐operatively); for one, to Class II; and for one, to Class II/III. 36‐Item Short‐Form Health Survey questionnaire scores also improved highly significantly.
Berlin Heals has now initiated a randomized, controlled trial in 100 DCM patients, which will take place in Germany, Austria, Serbia, and Poland.
In addition, the FDA has granted Breakthrough Device designation for the C-MIC system
Berlin Heals website: http://berlinheals.de/
Corvion is a pre-clinical stage company based in Webster, Texas. They are developing a fully-implantable LVAD that incorporates a highly efficient implantable rotary blood pump (Corvion claims 3X more efficient than competitors) coupled with a thin battery that gives 3 hours of free operation, and a robust transcutaneous energy transmission system.
Impulse Dynamics – the company for which I am CTO and Executive VP – received MR-conditional approval (1.5 T head/limbs with peripheral coils) from both FDA and the European Union.
From the press release:
IMPULSE DYNAMICS ANNOUNCES FDA APPROVAL FOR MAGNETIC RESONANCE IMAGING FDA
Clears Potential Hurdle for Many Heart Failure Patients
MARLTON, N.J.–(BUSINESS WIRE)–Impulse Dynamics, a company dedicated to improving the lives of people with heart failure (HF), today announced the U.S. Food and Drug Administration (FDA) has approved the conditional use of Magnetic Resonance Imaging (MRI) for Optimizer® CCM® delivery systems. This approval represents a significant advance because the population that benefits most from cardiac contractility modulation therapy (patients with moderate to severe HF) often requires advanced diagnostic imaging procedures.
Impulse Dynamics, Inc., a company dedicated to improving the lives of people with heart failure, today announced its innovative CCM® therapy delivered by the Optimizer® system received an award from the R&D 100 Awards, a prestigious program honoring research and development pioneers and their revolutionary ideas in science and technology.
“Winning this award is a tremendous accomplishment for our company as it represents the recognition by fellow scientists and engineers for the enormous effort that has gone into developing this breakthrough technology. The therapy serves a huge unmet need for a very large group of heart failure patients who suffer every day with their symptoms, so it’s great for the technology to receive recognition at this level,” said David Prutchi, Ph.D., Chief Technology Officer and Executive Vice President at Impulse Dynamics. “I am pleased to congratulate all my colleagues that helped evolve what was initially an intriguing electrophysiological discovery into the transformational therapy that it is today.”
Impulse Dynamics’ website: www.impulse-dynamics.com
CVRx’s BeAT-HF phase III randomized clinical trial results were published in the Journal of the American College of Cardiology (“JACC”). Results from the trial were used to obtain FDA PMA for the BAROSTIM NEO device for improvement of symptoms in patients with heart failure.
The main results for the study were:
- BAROSTIM NEO is safe to use for patients with HFrEF, with a MANCE-free rate of 97%.
- Clinically-significant improvements in patient-centered symptomatic endpoints as compared to the control group:
- Improved quality of life score by 14.1 (p<0.001) points in MLWHFQ.
- Improved exercise capacity by 60 meters (p<0.001) as measured by the standardized 6-minute hall walk test.
- Improved functional status as assessed by NYHA classification: 65% BAROSTIM NEO versus 31% control patients experienced NYHA class improvement (p<0.001).
- Significant 25% reduction in NT-proBNP (p<0.001).
Abbott today announced that the FDA has approved its next-generation Gallant™ line of ICD and CRT-D devices. According to the announcement:
“The devices bring new benefits to patients with heart rhythm disorders, including a patient-preferred design without compromising battery longevity and MRI compatibility. In addition, the new devices offer Bluetooth technology and a new patient smartphone app for improved remote monitoring, allowing for increased patient/physician engagement and streamlined communications.
The new Gallant system pairs with Abbott’s secure myMerlinPulse™, an iOS- and Android™- compatible mobile smartphone app that helps streamline communication between doctors and their patients. The app provides people with access to data, device performance, and transmission history, which helps them take an active role in their healthcare. Through the myMerlinPulse app, physicians can continuously monitor their patients remotely allowing for identification of asymptomatic episodes as well as patient-triggered transmissions, which can lead to earlier intervention and reduce clinical burden.”
Abbott received the CE Mark for these devices back in February 2020.
Portland-based Viscardia received FDA’s “Breakthrough Technology” designation for its VisONE® device, which delivers “Asymptomatic Diaphragmatic Stimulation” (ADS) therapy to improve cardiac function.
The idea is that by electrically stimulating the diaphragm in an asymptomatic manner, transient intrathoracic pressures gated to cardiac activity are applied against the cardiac walls, improving both cardiac filling and output.
VisCardia’s website: viscardia.com
Impulse Dynamics (where I’m Executive VP of Product Development) announced today the completion of an $80.25 Million Series D financing round with major new investors, including strategics. According to the press release:
“Impulse Dynamics, developer of Optimizer® Smart System for delivering CCM™ therapy, announced the completion of an $80.25 million Series D financing with new investors. The proceeds will be used primarily to facilitate U.S. commercialization of the Optimizer Smart, an FDA-approved implantable device for treating chronic heart failure that has been proven to strengthen the heart and help it beat more forcibly. Led by well-respected medical technology investor Amzak Health Investors, the round also included Wellington Management, Kennedy Lewis Investment Management, Acorn Biosciences and Minth Holdings Limited; strategic investors Zoll Medical Corporation, Abiomed and one additional corporate investor; and the company’s chief executive and chief financial officers.”
Impulse Dynamics – the company for which I’m Executive VP of Product Development – announced that it has secured transitional pass-through (TPT) payment for the OPTIMIZER Smart System for the treatment of heart failure.
CMS has affirmed the substantial clinical improvement that Cardiac Contractility Modulation (CCM™ therapy) offers to patients with heart failure and adjusted the payment offered for the technology accordingly to facilitate access. The new payment, issued on Friday, Nov. 1, 2019 in CMS’s calendar year 2020 Outpatient Prospective Payment System (OPPS) final rule, eases access to CCM therapy in the hospital outpatient setting, with improved reimbursement taking effect on Jan. 1, 2020.
Medtronic announced today its financial results for its first quarter of fiscal year 2020. As a whole, the company reported first quarter worldwide revenue of $7.493 billion, an increase of 1.5 percent.
However, Cardiac Rhythm & Heart Failure decreased 3.1 percent as reported (1.2 percent on a constant currency basis). According to the press release”
“Arrhythmia Management grew in the mid-single digits on a constant currency basis, driven by mid-single digit growth in Pacemakers, including mid-twenties growth of the Micra® transcatheter pacing system, as well as mid-thirties growth of the TYRX® absorbable antibacterial envelope, high-single digit growth of the Reveal LINQTM insertable cardiac monitoring system, and high-single digit growth in AF Solutions, all on a constant currency basis. Arrhythmia Management growth was offset by low-double digit declines in Heart Failure, including high-forties declines in sales of left ventricular assist devices (LVADs), both on a constant currency basis.”
Pain Therapies, the other area of Medtronic’s business that depends heavily on active implantable medical devices also took a hit, with first quarter revenue of $292 million decreased 7.0 percent as reported or 6.1 percent on a constant currency basis. The announcement explains:
“Pain Stimulation declined in the low-double digits, reflecting channel destocking and the overall slowdown of the spinal cord stimulation market.”
Minneapolis-based CVRx received FDA approval yesterday for its BAROSTIM NEO™ device to treat Heart Failure.
The BAROSTIM NEO™ implantable pulse generator is implanted below the collar bone and is connected to a lead that attaches to the carotid artery in the neck, targeting its baroreceptors. The proposed mechanism of action is that the activation of baroreceptors cause the brain to relax the blood vessels and inhibit the production of stress-related hormones to reduce heart failure symptoms.
The no-panel approval was based on results from CVRx’s BeAT-HF phase III trial on 264 patients randomized to two arms: 130 subjects randomized to receive a BAROSTIM NEO™ were compared to 134 subjects randomized to stay on guideline-directed medical therapy. The implanted group showed the following improvement in symptomatic endpoints as compared to the control group:
- Improved their MLWHFQ score by 14 points,
- Improved their 6-minute hall walk by 60 meters, and
- Improved their NYHA status.
According to FDA’s press release, the BAROSTIM NEO™ System is indicated for the improvement of symptoms in patients with advanced heart failure (EF≤35%) who are not suited for treatment with other heart failure devices.
CVRx website: www.cvrx.com
Berlin Heals GmbH – a private Switzerland-based company with an R&D branch in Berlin, Germany – started a FIH-Pilot-Trial of its C-MIC device at AKH Vienna and at the Hospital Center Dedinje in Belgrade.
The C-MIC is an implantable electroceutical device intended to readjust the disturbed myocardial electrical gradient that, according to Berlin Heals, occurs in heart failure patients.
Dr. Peter Göttel from Berlin Heals told me that as of today, 4 patients have been implanted between the two sites.
Berlin Heals website: http://berlinheals.de/
Berlin Heals announcement: http://berlinheals.de/pilot-study-initiated/