At HRS, Medtronic presented positive data from a post-approval registry of Micra, which included 795 patients in 97 centers worldwide. The results showed the device had a 99.6% implant success rate and a major complication rate of just 1.5% at 30 days, despite the fact that roughly 87% of physicians involved in the trial were new implanters without any previous Micra experience.
Boston Scientific is also chugging along with the development of its Empower leadless pacemaker (pictured in the slide). Data from an animal study, presented at HRS, showed that the device delivers appropriate pacing therapy and receives communication from the company’s subcutaneous ICD (S-ICD). The findings, which also were published in the Journal of the American College of Cardiology: Clinical Electrophysiology, proved the feasibility of the leadless pacemaker design and modular system.
Of the 40 animals in the study, 39 were successfully implanted with the device and 23 were followed out to 90 days after implantation. Key objectives included studying intrabody communication between the S-ICD and the leadless pacemaker, as well as the delivery of anti-tachycardia pacing therapy. Communication between the S-ICD and the leadless pacemaker was successful in 99% of the 401 attempts, and anti-tachycardia pacing was delivered 100% of the time the communication was received. For more details on the Empower leadless pacemaker and what is next for the technology, see this story, from Qmed’s sister publication, MD+DI.
Abbott Laboratories inherited the Nanostim leadless pacemaker as part of its acquisition of St. Jude Medical, but the technology has encountered some technical issues that has stood in the way of FDA approval.
2 – CRT Devices are Getting Smarter
Medtronic is gearing up to launch a new platform of MR-conditional quadripolar cardiac resynchronization therapy pacemakers (CRT-Ps), which recently won FDA approval. The new devices – Percepta Quad CRT-P MRI SureScan, Serena Quad CRT-P MRI SureScan, and Solara Quad CRT-P MRI SureScan – are designed to allow clinicians to provide more personalized therapy options, and patients with one of these pacemakers implanted can receive MRI scans in either 1.5 or 3 Tesla machines. The CRT-P portfolio received CE mark in February.
David Steinhaus, MD, vice president and general manager of Medtronic’s heart failure business, told Qmed the new platform includes a chip set that allows the company to iterate on the platform much more quickly than it has been able to do in the past. The devices also come fully loaded with bells and whistles from Medtronic’s CRT-Ds. For more details on the new platform, see this recent Qmed story.
Boston Scientific attracted attention during HRS with its recently FDA-approved Resonate ICD devices. Matson highlighted four key differentiating features of the new devices in his report, and said that these features should help the company gain share in the ICD market:
· Resonate features the EnduraLife battery technology that provides longer life, which Matson said is up to two times the battery life of competitors’ ICDs.
· Resonate is expected to have MRI conditional labeling, pending FDA approval, by the fourth quarter.
· Resonate will offer SmartCRT therapy, which consists of quad pole pacing, Smart Delay, and MultiSite Pacing, while still providing up to a 13.3-year life, Matson said.
· Resonate features HeartLogic, which is Boston Scientific’s heart failure diagnostics algorithm that has demonstrated a 70% sensitivity in detecting heart failure events at a median of 34 days in advance.
For more details on the Resonate ICD devices, see this recent Qmed story.
Data presented at HRS also showed that Boston Scientific’s subcutaneous implantable defibrillator (S-ICD) system is passing muster in the real world. Data from the company’s post-market approval study, presented at HRS, showed the therapy effectively terminated heart arrhythmias in 98.7% of evaluated patients, and had a complication-free rate of 96.2% at 30 days post-procedure. For more details about this study, which the company said is the largest S-ICD study to date (1,637 patients implanted with the device at 86 U.S. centers), see this recent Qmed story.
"We think that these results show that the S-ICD has potential for broad use, rather than simply being a niche product," Matson said.
3 – Balloon Ablation Catheters are Gaining Traction
Medtronic’s Arctic Front Advance Cryoablation catheter system has continued to gain share, Matson noted, and the analyst estimated that the product’s sales now exceeds $600 million a year. The growth has mostly come from expanding the market to electrophysiologists (EPs) that weren’t trained in catheter RF ablation, Matson said, by offering an easier procedure rather than converting catheter-trained EPs.
Another up-and-comer in the space, CardioFocus, gained FDA approval last year for its Heartlight endoscopically-guided laser AF ablation system. Heartlight also uses a balloon-based system designed to be easier to use than a conventional RF catheter.
While there hasn’t been any evidence yet that CardioFocus is gaining share from Medtronic, Matson said Heartlight could emerge as a more significant threat if a larger company, such as Boston Scientific, Johnson & Johnson, or Abbott were to acquire CardioFocus. The analyst also noted that there are other balloon-based ablation catheters in development, including Apama Medical’s RF energy balloon.
CardioFocus was a finalist for MD+DI’s Manufacturer of the Year award in 2012.
4 – TAVR is Getting Even Hotter
Edwards Lifesciences continues to lead the way in the transcatheter aortic valve replacement (TAVR) market. During EuroPCR, the company released data demonstrating excellent clinical outcomes for TAVR patients treated with the Edwards Centera valve. These new 30-day results are the first data presented on the company’s self-expanding valve.
For severe, symptomatic aortic stenosis patients considered high risk for open-heart surgery, the Centera valve demonstrated a survival rate of 99%, a 2.5% rate of disabling stroke, and a 4.9% permanent pacemaker rate, which Edwards noted is the lowest rate ever reported in a multicenter trial for a self-expanding valve.
Additionally, the company said, there was a 0.6% rate of moderate paravalvular leak (PVL) among patients, and no severe PVL. All 203 patients in the CENTURA-EU study were treated via the transfemoral access route, and most of them (174 patients) were treated under conscious sedation.
Edwards has designed its newest valve to be repositionable, and retrievable, and the device can be delivered through a low-profile 14-French delivery system that features a motorized handle designed to offer stable valve deployment.
Edwards said it anticipates getting CE mark approval for the Centera valve during the fourth quarter.
Also during EuroPCR, Edwards reported that new one-year data from the SOURCE 3 registry, a European post-approval study of the Sapien 3 valve, demonstrated positive patient outcomes, including high survival rates and low rates of stroke and PVL.
The post-approval study included 1,946 patients. At one year, patients treated via the transfemoral access route had a survival rate of 88.2%, and a disabling stroke rate of only 1.1%. These patients also experienced a 2.7% rate of moderate PVL, and no severe PVL, Edwards noted. Most of the patients included in the registry were treated via transfemoral access, and more than half were treated under conscious sedation, the company said. Patients were enrolled at 80 centers across 10 countries between July 2014 and October 2015, and the company plans to follow them for five years.
Boston Scientific has had a tougher time finding its place in the TAVR market, but the company’s Lotus valve system demonstrated superior efficacy compared to Medtronic’s CoreValve platform at one year, according to pivotal study results presented at EuroPCR.
The REPRISE III trial is the first head-to-head pivotal study comparing two different TAVR platforms, the company said. The multicenter, randomized controlled trial included 912 patients from the United States, Europe, Canada, and Australia with severe aortic stenosis who were considered to be at high or extreme risk for surgical valve replacement.
While Lotus was superior compared to CoreValve in terms of PVL at one year, and in terms of disabling stroke rate, the device did demonstrate a higher rate of permanent pacemaker implants after the procedure (29.1%) compared to CoreValve (15.8%).
For more details about the Lotus data presented at EuroPCR, see this recent Qmed story.
5 – Technology is Closing in on Stroke Rates
W.L. Gore & Associates released data from the REDUCE study at the European Stroke Organization Conference in Prague, which ran at the same time as EuroPCR. According to the study, Gore’s Cardioform septal occlude can reduce the risk of recurrent stroke by more than 76% when combined with antiplatelet therapy, compared to antiplatelet therapy alone.
Gore is playing catch-up with Abbott, which inherited the Amplatzer device through its acquisition of St. Jude Medical. FDA approved the Amplatzer device for the same use last year. Gore said it plans to submit the data from this study to FDA by the end of this year. For more details about Gore’s REDUCE study, see this recent Qmed story.
Another technology that is proving to be effective at stroke reduction is Boston Scientific’s Watchman left atrial appendage closure (LAAC) device. Results from the company’s EWOLUTION registry of Watchman showed it had a high implant success rate, low ischemic stroke and major bleeding rates, and was effective in stroke reduction for patients with non-valvular atrial fibrillation.
“Watchman remains the only catheter-delivered LAAC device in the U.S. and we expect this data to help continue to drive significant growth,” Matson said in his report.
6 – FFR May Land a New Role in the Cath Lab
Revealing a potential new role for fractional flow reserve (FFR) in cath labs, investigators from the Erasmus Medical Center unveiled early results from the independent, physician-sponsored FFR-Search Registry during a late-breaking trial session at EuroPCR.
Using the Navvus Rapid Exchange FFR MicroCatheter from Acist Medical Systems Inc., the investigators found that microcatheter-based FFR was feasible in various clinical settings, including acute coronary syndromes and ST elevation myocardial infarction, and almost half of patients had an FFR lower than 0.90 after PCI. These early results did not have a meaningful impact on 30-day clinical outcomes, but patients will now be followed out to the two-year primary endpoint to shed more definitive light on the value of post-PCI FFR in clinical practice.
The registry enrolled more than 1,000 consecutive patients with stable angina or acute coronary syndromes that had undergone PCI at Erasmus Medical Center in Rotterdam to determine the association of post-PCI FFR values on clinical outcomes, as measured at 30-days, one year, two years, and five years. In an attempt to replicate real-world clinical practice, the study protocol precluded operators from additional optimization techniques after the initial stent placement.
“The preliminary data from FFR-Search has the potential to significantly expand this technology’s role in the cath lab in the future, which is why we’re eager to see the important results of the primary endpoint at two years,” said Nicolas M. Van Mieghem, MD, PhD, co-principal investigator and director of interventional cardiology at Thoraxcenter, Erasmus Medical Center.
Tom Morizio, president and CEO of Acist Medical Systems, said the company’s differentiated microcatheter technology is designed to allow physicians the ability to perform rapid FFR measurements before, during, and after intervention, all while maintaining their guidewire position. “We feel that we are uniquely suited to address this new role of FFR compared to other FFR measurement modalities, including pressure wire-based FFR,” Morizio said.