Six Emerging Trends Shaping the Cardiac Device Industry: Innovations in Leadless Pacemakers, CRT, Balloon Ablation, TAVR, Stroke Prevention, and FFR Applications

During the annual Heart Rhythm Society (HRS) Scientific Sessions and the European Association of Percutaneous Cardiovascular Interventions (EuroPCR) congress, medtech companies released a substantial volume of cardiovascular news and data over the past two weeks. These represent the hottest device trends among the series of conferences held this year.

1

Leadless Cardiac Pacemakers Gain Attention

During the Heart Rhythm Society (HRS) annual meeting held in Chicago this year, leadless cardiac pacemakers remained a hot topic, which is hardly surprising given the estimated market potential of this technology.

In a recent report, Mike Matson, an analyst at Needham & Company, pointed out that the global potential market value of leadless cardiac pacemakers is approximately $1.2 billion, with a market penetration rate of 100%. However, he also noted that the price premium of these devices may limit market penetration, particularly in the European market. For instance, Medtronic’s Micra leadless cardiac pacemaker is priced at $10,000, which Matson stated is roughly twice the price of standard pacemakers. Although Micra received FDA approval for market launch in April 2016, initial sales were slow due to limited reimbursement coverage. However, since Medicare beneficiaries became eligible for reimbursement in March, the device is now expected to become a key driver of market growth.

At the Heart Rhythm Society (HRS) annual scientific sessions, Medtronic presented positive post-approval data for Micra, encompassing 795 patients from 97 centers worldwide. The results demonstrated that although approximately 87% of the implanting physicians were novices with no prior experience in Micra implantation, the device achieved a 99.6% implantation success rate at 30 days, with a major complication rate of only 1.5%.

Boston Scientific Corporation is also growing stronger with the development of its Empower leadless pacemaker (as shown in the slides). Animal study data presented at the HRS conference demonstrated that the device can deliver appropriate pacing therapy and receive communication signals from the company’s subcutaneous implantable cardioverter-defibrillator (S-ICD). These findings, also published in JACC: Clinical Electrophysiology, confirm the feasibility of the leadless pacemaker design and modular system.

Among the 40 animals included in the study, the device was successfully implanted in 39, with 23 followed up to 90 days post-implantation. The primary objective was to investigate in vivo communication between the subcutaneous implantable cardioverter-defibrillator (S-ICD) and the leadless cardiac pacemaker, as well as the delivery of antitachycardia pacing therapy. Across 401 attempts, the communication success rate between the S-ICD and the leadless cardiac pacemaker was 99%, and the success rate for antitachycardia pacing during communication reception was 100%.

After acquiring St. Jude Medical, Abbott Laboratories incorporated the Nanostim leadless cardiac pacemaker into its portfolio; however, due to certain technical issues with the device, it encountered obstacles in obtaining FDA approval.

2

CRT Devices Are Becoming Increasingly Intelligent

Medtronic is accelerating the launch of a new line of MRI-conditional quadrupolar cardiac resynchronization therapy pacemakers (CRT-Ps), which recently received FDA approval. The Percepta Quad CRT-P MRI SureScan, Serena Quad CRT-P MRI SureScan, and Solara Quad CRT-P MRI SureScan are designed to provide clinicians with more personalized treatment options, allowing patients implanted with any of these devices to undergo MRI scans on 1.5 Tesla or 3 Tesla machines. The CRT-P series received CE marking in February.

Vice President and General Manager, Heart Failure Business, MedtronicMedicineDr. David Steinhaus told Qmed that the new platform includes a chipset enabling the company to iterate on the platform more rapidly than ever before. In addition, these devices are equipped with additional features derived entirely from Medtronic’s CRT-D.

During the HRS conference, Boston Scientific’s Resonate ICD device, which recently received FDA approval, garnered attention. In his report, Matson highlighted four key features of the new device and stated that these functionalities would help the company gain market share in the ICD segment:

Resonate features EnduraLife battery technology, providing a longer service life that is twice the battery life of competitors’ ICDs, according to Matson.

Prior to the fourth quarter, Resonate is expected to undergo MRI-conditional labeling before FDA approval.

Matson stated that Resonate will provide SmartCRT therapy, including quadripolar pacing, intelligent delay, and MultiSite pacing, while also offering a battery life of up to 13.3 years.

Resonate’s HeartLogic feature utilizes Boston Scientific’s heart failure diagnostic algorithm, demonstrating 70% sensitivity in detecting heart failure events with a median lead time of 34 days.

Data presented at the HRS meeting also demonstrated that Boston Scientific’s Subcutaneous Implantable Cardioverter-Defibrillator (S-ICD) System has achieved favorable market reception. Post-approval study results published by the company at HRS showed that arrhythmias were effectively terminated in 98.7% of evaluated patients following therapy, with a 30-day post-procedure complication-free rate of 96.2%.

Matson stated, “We believe these results demonstrate the potential for widespread application of the S-ICD, rather than it being merely a niche product.”

3

Balloon Ablation Catheters Are Gaining Increasing Popularity

Analyst Matson pointed out that Medtronic’s Arctic Front Advance cryoballoon catheter ablation system continues to gain market share, with estimated annual sales currently exceeding $600 million. Matson further stated that this growth is primarily attributable to expanding the market to electrophysiologists (EPs) who have not undergone training in catheter-based radiofrequency ablation, by offering a simpler procedural workflow that eliminates the need for EPs to receive such training.

As a latecomer to the field, CardioFocus received FDA approval last year for its Heartlight endoscope-guided laser automatic focusing ablation system. The Heartlight system also employs a balloon-based platform, designed to be easier to use than conventional RF catheters.

Although there is no evidence yet that CardioFocus is gaining market share from Medtronic, the Heartlight system could pose a greater threat if acquired by major companies such as Boston Scientific, Johnson & Johnson, or Abbott. Analysts also note that other balloon-based ablation catheters are under development, including Apama Medical’s radiofrequency energy balloon.

4

TAVR is Gaining Increasing Popularity

Edwards Lifesciences continues to maintain its leading position in the transcatheter aortic valve replacement (TAVR) market. Data released by the company during the European Association of Percutaneous Cardiovascular Interventions (EuroPCR) conference demonstrated the superior clinical outcomes of Edwards’ Centera valve in patients undergoing TAVR therapy. These new 30-day results mark the company’s first release of data on its self-expanding valve.

Edwards pointed out that for high-risk patients with severe aortic stenosis undergoing cardiac surgery, the survival rate with the Centera valve was 99%, the stroke-related disability rate was 2.5%, and the permanent pacemaker implantation rate was 4.9%, which were the lowest rates ever reported in multicenter clinical trials of self-expanding valves.

Furthermore, the company reported that the incidence of moderate paravalvular leak (PVL) was 0.6%, with no cases of severe PVL observed. All 203 patients in the CENTURA-EU study were treated via the transfemoral approach, with the majority (174 patients) receiving treatment under conscious sedation.

The latest valve designed by Edwards is repositionable and retrievable. The device can be delivered via a low-profile 14-French delivery system, whose motorized handle is designed for stable valve deployment.

Edwards stated that the Centera valve is expected to receive CE certification in the fourth quarter.

Furthermore, during the EuroPCR (European Association of Percutaneous Cardiovascular Interventions) conference hosted by the European Society of Cardiology, Edwards presented new one-year data from the SOURCE 3 Registry (SAPIEN Aortic Bioprosthesis European Outcome Registry), which demonstrated favorable patient outcomes, with high survival rates and low incidences of stroke and paravalvular leak (PVL).

This post-market study enrolled 1,946 patients. Among those treated via the transfemoral approach, the one-year survival rate was 88.2%, and the stroke-related disability rate was only 1.1%. Edwards noted that the incidence of moderate paravalvular leak (PVL) in these patients was 2.7%, with no cases of severe PVL observed. The company stated that the majority of enrolled patients underwent treatment via the transfemoral approach, and more than half received treatment under conscious sedation. Patients were enrolled between July 2014 and October 2015 across 80 centers in 10 countries, and the company plans to follow them up for five years.

Boston Scientific Corporation has had a difficult time finding its place in the TAVR market; however, according to key study results presented at EuroPCR, the company’s Lotus valve system demonstrated superiority over Medtronic’s CoreValve platform in terms of one-year efficacy.

The company stated that the REPRISE III trial is the first head-to-head pivotal study comparing two different TAVR platforms. This multicenter, randomized, controlled trial enrolled 912 patients with severe aortic stenosis at high or very high risk for surgical valve replacement from the United States, Europe, Canada, and Australia.

Although Lotus was superior to CoreValve in terms of 1-year PVL, the device had a higher rate of permanent pacemaker implantation post-procedure (29.1%) compared with CoreValve (15.8%), while showing no significant difference in disabling stroke rates.

5

Technology Is Reducing the Incidence of Stroke

W.L. Gore & Associates presented data from the REDUCE study at the European Stroke Organisation Conference in Prague, held concurrently with EuroPCR. According to the study, Gore’s ventricular septal occluder combined with antiplatelet therapy reduced the risk of recurrent stroke by more than 76% compared with antiplatelet therapy alone.

Gore is catching up with Abbott, which inherited the Amplatzer device through its acquisition of St. Jude Medical; the FDA approved the same indication for the Amplatzer device last year. Gore stated that it plans to submit the study data to the FDA by the end of this year.

Another technology that can effectively reduce stroke is the Watchman left atrial appendage closure (LAAC) device from Boston Scientific. The company’s EWOLUTION registry results show that it has a high implantation success rate, low incidence of ischemic stroke and major bleeding, and can effectively reduce the occurrence of stroke in patients with non-valvular atrial fibrillation.

Matson stated in his report, “In the United States, Watchman remains the only catheter-delivered LAAC device, and we expect these data to help continue driving its significant growth.”

6

FFR Can Play a New Role in the Catheterization Laboratory

During a recent breakthrough clinical trial session at EuroPCR, researchers from Erasmus Medical Center presented early results from the independent, physician-initiated FFR-Search registry, revealing a potential new role for fractional flow reserve (FFR) in the catheterization laboratory.

Using the Navvus Rapid Exchange FFR Microcatheter from Acist Medical Systems, researchers found that microcatheter-based FFR can be used in various clinical settings, including acute coronary syndrome and ST-segment elevation myocardial infarction. After PCI, nearly half of the patients had an FFR below 0.90. These early results did not have a meaningful impact on 30-day clinical outcomes, but patients will now be followed up to two years for the primary endpoint to clarify the actual post-PCI FFR values in clinical practice.

More than 1,000 patients with stable angina or acute coronary syndrome undergoing PCI were consecutively enrolled at Erasmus Medical Center in Rotterdam to determine the relationship between post-PCI FFR values and clinical outcomes, which were assessed at 30 days, one year, two years, and five years. To attempt to replicate real-world clinical practice, the study protocol prohibited operators from employing additional optimization techniques after initial stent implantation.

Dr. Nicolas M. Van Mieghem, Principal Investigator and Director of Interventional Cardiology at the Thoraxcenter, Erasmus Medical Center, stated, “Preliminary data from FFR-Search may significantly expand the application of this technology in the catheterization laboratory in the future; therefore, we also look forward to seeing the key results for the two-year primary endpoints.”

Tom Morizio, President and Chief Executive Officer of ACIST Medical Systems, stated that the company’s differentiated microcatheter technology is designed to enable physicians to perform rapid FFR measurements before, during, and after interventional procedures while maintaining the position of their guidewire. “We believe we are uniquely suited for this new role in FFR compared to other FFR measurement modalities, including wire-based pressure FFR,” said Morizio.

W. L. Gore & Associates is catching up with Abbott, which inherited the Amplatzer device through its acquisition of St. Jude Medical. The FDA approved the same indication for the Amplatzer device last year. Gore stated that it plans to submit the study data to the FDA by the end of this year.

Another technology that can effectively reduce stroke is the Watchman left atrial appendage closure (LAAC) device from Boston Scientific. The company’s EWOLUTION registry results show high implantation success rates, low incidence of ischemic stroke and major bleeding, and effective reduction of stroke occurrence in patients with non-valvular atrial fibrillation.

Matson stated in his report, “In the United States, Watchman remains the only catheter-delivered left atrial appendage closure (LAAC) device, and we expect these data to continue driving its significant growth.”

Source: Medtec Medical Device Design and Manufacturing