The EuroPCR conference wrapped up this week in Paris. Here’s a roundup of news from the largest overseas meeting of interventional cardiologists, dominated by Edwards Lifesciences‘ (NYSE:EW) decision to pause its Fortis transcatheter mitral valve implant trial:
TMVI: Edwards pauses Fortis trial
Edwards said it paused enrollment on Fortis after finding blood clots in some of the 20 patients.
“We observed evidence of valve thrombosis that we believe warrants additional investigation,” the Irvine, Calif.-based company company said, adding that it’s unsure if Fortis program will advance to CE Mark trials.
Leerink Partners analyst Danielle Antalffy said it might be late this year before Edwards decides whether to proceed with Fortis or another of its other TMVI candidates. The company also "may be willing" to advance its mitral valve program via acquisition, with Neovasc (NASDAQ:NVCN) a prime candidate, Antalffy wrote this week in a note to investors.
Edwards "has been transparent in the recent past about uncertainty as to whether Fortis will be the program that advances to CE Mark trials," she wrote. "We also believe EW may be willing to advance into TMVR through M&A, with a number of companies – notably NVCN – near or already enrolling feasibility studies. Ultimately, we continue to believe TMVR represents complete upside to what we believe is already a sustainable double-digit sales growth outlook longer term."
Mitralign said it’s a step closer to CE Mark approval for its mitral repair device, reporting that a prospective, multi-center study met 30-day safety endpoints and 6-month performance endpoints.
Mitralign’s percutaneous annuloplasty system demonstrated a significant reduction in left ventricular diameter, significant reduction of both the A-P and S-L annular dimensions and a significant improvement of the patient’s walking distance, the company said.
"It is noteworthy that the Mitralign system has demonstrated safety and performance in a very challenging FMR patient population. The patients were all on optimal medical therapy and had an average ejection fraction of 33%. Such data illustrate the value this system brings to those patients dealing with FMR," CEO Rick Geoffrion said in a press release.
TAVI: Major, minor players report good data
Edwards presented data from a 5-year, multicenter, non-randomized trial designed to evaluate patients annually. A 101-patient subset analysis of intermediate-risk patients showed a 1% mortality rate after 30 days, Edwards said.
The disabling stroke rate was 2%, major vascular complications were 2% and the permanent pacemaker rate was 4%, the study found. Edwards also reported a 2.3% rate of paravalvular regurgitation and no reports of severe leaks.
"The 1-year survival rate in the transfemoral cohort is the highest reported in a multicenter, fully adjudicated TAVI study to date. These results set a new standard of care for patients at high risk for surgical aortic valve replacement. The results of the Sapien 3 trial via the transfemoral approach also raise the question of whether transcatheter valve replacement should be considered for approval for all elderly patients with severe aortic stenosis," principal investigator Dr. John Webb of Vancouver’s St. Paul’s Hospital said in a press release.
A 1-year analysis of the 1st 150 patients enrolled in the Sapien 3 trial showed a 1-year survival rate of 91.6% with a 1.1% rate of disabling strokes and 2% occurrence of moderate paravalvular leaks, Edwards said.
- Medtronic reported 6-month data on its next-generation CoreValve Evolut R device, saying the 60-patient CE Mark trial showed a 95% survival rate, a 1.7% stroke rate and a 7.4% paravalvular leakage rate, with no severe leakage, according to Antalffy.
- Boston Scientific presented data on its Lotus transcatheter aortic valve implant, reporting a mortality rate under 2% at 30 days according to a new study.
The data comes from a 250-patient cohort in the Respond post-market study of patients implanted with the Lotus device. The study reports a 95% freedom from paravalvular leakage, and a mortality rate at 1.6% in the first 30 days Boston Scientific said.
Rates of PVL from the 250-patient Reprise II study were also presented at EuroPCR, with 86% of patients free of paravalvular leakage, 14% with mild PVL and less than 1% with moderate PVL.
"These results are further evidence that the Lotus valve design, its precise placement and redeployment capabilities and its low rates of paravalvular regurgitation can make a significant and meaningful difference in the lives of patients," chief medical officer Dr. Keith Dawkins said in a press release.
- St. Jude Medical told MassDevice.com last year that they paused their Portico implants to ensure patient safety over concerns of leaflet motion observations, but new data presented at EuroPCR has helped diminish concerns, a spokesman told us this week.
Data from 3 separate single-center studies of 345 patients with TAVI devices showed that leaflet abnormalities were not associated with clinical events like stroke or valve failure, and that leaflet thickening was not unique to any particular device. Most leaflet abnormalities resolved with use of oral anticoagulants, according to the data.
"At the present time, there is no evidence to support a change in patient selection, procedural aspects, or post-procedural management for transcatheter aortic valve implantation or surgical aortic valve replacement, but the findings call for further studies," Dr. Lars Søndergaard of Rigshospitalet, Denmark, said at EuroPCR.
St. Jude spokesman Justin Paquette said Søndergaard’s study and others "confirm the results of St. Jude Medical’s own initial review. The collective evidence generated to date suggests that the observation does not impact valve clinical performance or increase patient risk for adverse outcomes, and that there is no need to modify or restrict current TAVI/TAVR programs."
Competitors reaching parity with Sapien 3?
Although Sapien 3 has the edge in "best-in-class" status among physicians due to its ease of use and low stroke and PVL rates, Antalffy wrote, "the conversations at this meeting were definitively increasingly positive on competitive valves, with more and more positive data on next-gen devices like MDT’s Evolut R, BSX’s Lotus, and with STJ’s Portico now resuming implants," she wrote.
"It’s becoming increasingly clear that each device has its attractive features and benefits – i.e., repositionability for Evolut R and Lotus, ease of delivery for Evolut R and Sapien 3, dramatically low PVL rates for Lotus despite what we’ve heard to be a somewhat bulkier and more cumbersome delivery system," Antalffy wrote. "But it seems that EW is retaining its market-share leading position with Sapien 3, given positive outcomes and attractive features across the board, as well as its being the only balloon expanding device on the market."
Low PVL rates could set Direct Flow Medical‘s TAVI device apart, as that company presented new data at the conference showing a 98% survival rate and a 97% rate of mild or no aortic regurgitation. The stroke rate was 2%, and the rate of myocardial infarction was 0.6%, the company said.
“Treating patients with the Direct Flow Medical valve in a real-world setting and getting the same consistent results seen in the clinical trial shows outstanding performance. In daily practice we are faced with patients that are normally excluded by protocol from clinical studies, but these patients need treatment, as well. It is reassuring to know that we can reproduce the same results in challenging clinical scenarios with this valve,” said Dr. Christoph Naber of Essen, Germany’s Contilia Heart Center.
Here’s a look at other news from EuroPCR:
Medtronic presented clinical data from the 1,500-patient study of its In.Pact Admiral drug-eluting balloon, designed to treat lesions in the superficial femoral and popliteal arteries.
Twelve-month data on a subset of 157 patients with long lesions (average length 26.4cm ± 8.61cm) showed a 94% rate of freedom from adverse events and no target limb amputations, Medtronic said.
The study reported a 6% rate of clinically-driven target lesion revascularization and a primary patency of 91.1% after 360 days. Data from a separate 12-month, 105-patient Italian study showed a 4% rate of CD-TLR and a primary patency of 89.4% after 360 days, the company said.
“For patients with peripheral arterial disease in the lower extremities, long lesions pose a notoriously difficult treatment challenge. That’s why the 12-month results in this long-lesion subset are so impressive. The results are also remarkably consistent with those from similar studies of the In.Pact Admiral drug-coated balloon, irrespective of lesion length,” study investigator Dr. Dierk Scheinert of Leipzig, Germany’s University-Hospital said in prepared remarks.
The In.Pact Admiral device won FDA approval in December 2014 for percutaneous transluminal angioplasty, and won CE Mark approval in the European Union in 2009.
St. Jude touts 15-year benefits of FFR
St. Jude Medical (NYSE:STJ) said a new 15-year report on its fractional flow reserve technology confirms positive benefits found in original 5-year study and a 6.5 times lower risk for myocardial infarction.
HeartFlow FFR availability changes CAD patient management
HeartFlow said new data shows significant differences in physician management decisions depending on the availability of FFR analysis.
Svelte Medical plans for IDE study of wire-delivered stent
Svelte Medical Systems released 1-year clinical results of its CE Mark trial study and announced it is planning a pivotal IDE study in the U.S.
Elixir Medical’s bio-stent shows complete reabsorption
Elixir Medical Corp said a new study of its DESolve novolimus eluting stent showed complete bioreabsorbtion of the device after three years.
Cardiovascular Systems Diamondback 360 reports 50% paclitaxel absorption
Cardiovascular Systems (NSDQ:CSII) said a new report from a 2-year study of patients treated with its Diamondback 360 orbital hysterectomy system showed a 50% rate of facilitate absorption in calcified arteries.
Stentys touts 100% implant rate with novel ‘self-apposing’ stent
Stentys said a new study reports a 100% technical and angiographic success rate for its novel ‘self-apposing’ stent that uses a balloon to remove the stent sheath at the implantation location.
Avinger Pantheris study meets efficacy endpoints
Avinger (NSDQ:AVGR) said a study of its Pantheris lumivascular PAD treatment met efficacy endpoints with residual stenosis of less than or equal to 50% in 96% of lesions.
Biotronik’s Osiro hybrid better for high-risk patients
Biotronik says data from a 407-patient subset with acute ST-segment elevation myocardial infarction showed 3.4% failure rate at its endpoint with the company’s hybrid stent versus an 8.8% failure rate with traditional stents.
InspireMD’s CGuard stent study shows 100% success rate
InspireMD (OTC:NSPR) says a data from a study of 71 patients treated with its CGuard stent show a 100% procedure and system success rate with no major adverse cardiac or neurological events.
Reva touts Fantom bioresorbable stent data
Reva Medical (ASX:RVA) says a new study of its Fantom bioresorbable stent shows a 100% technical and procedural success rate with no major adverse cardiac events or myocardial infarction.