Minimally invasive structural heart implants are moving from mitral into tricuspid valve repair, as well as mitral valve replacement. Abbott Laboratories is presenting its latest data on all these fronts at the virtual PCR e-Course held by the European Association of Percutaneous Cardiovascular Interventions from June 25 to 27. The event is being held after the EuroPCR conference slated for May was canceled due to the pandemic.

The Abbott Park, Ill.-based company is among only a handful of big med techs to have a valuation that is higher now than it was at the start of the year. It is sheltered from declines in hospital procedures by its established pharmaceuticals, diagnostics and nutrition businesses.

Mitraclip gets real

Real-world outcomes data for the transcatheter mitral valve repair device Mitraclip in more than 1,000 patients were presented for the third-generation device. Abbott also offered data for two first-in-class devices: Triclip for transcatheter tricuspid valve repair and Tendyne for transcatheter mitral valve replacement. Both have received a CE mark and are aiming for a U.S. FDA approval.

“We’re pleased with the results from the real-world analyses of the EXPAND study, which show the positive impact of our third-generation Mitraclip NTR/XTR system in treating patients with significant mitral regurgitation (MR),” said Abbott spokesperson Mary Kokkinen. “These data, along with what we’ve seen in numerous clinical studies, further support the utility of our proven clip-based technology, which has been used to treat more than 100,000 patients with mitral valve disease since the therapy was first approved in 2013. The EXPAND results show positive real-world outcomes and quality of life improvements in reducing the debilitating symptoms of primary and secondary MR and align with what we’ve seen in previous clinical trials.”

Abbott asserted that Mitraclip is leading in terms of safety and effectiveness, according to the largest dataset yet produced for minimally invasive mitral valve repair. The global EXPAND study found that MR was reduced to less than 1+ for 87.1% of primary MR patients, with 90.1% of secondary MR patients achieving this.

Wall Street has supported Abbott, which has various COVID-19-related businesses, including diagnostics, blood glucose monitoring and minimally invasive devices. Type 2 diabetes and cardiovascular conditions are both contributors to an elevated risk for severe illness and death. Better managing them in a manner that limits physician contact and hospitalization is a key goal in the unfolding pandemic.

With Mitraclip, analysts are clearly intrigued by Edwards Lifesciences Corp. competitor Pascal. That device is in a head-to-head trial with Mitraclip known as CLASP IID/IIF in patients with degenerative MR who are not suited to mitral valve surgery and in those with functional MR on guideline-directed medical therapy. Primary endpoint data aren’t anticipated until the end of 2023.

Still, the latest iteration of Mitraclip is seen as a formidable competitor. “The Mitraclip G4 system, which has independently controlled grippers that allow physicians to grasp one or both of the leaflets during the procedure, received high marks from the panel participants,” Cowen’s Joshua Jennings said on views from key opinion leaders. “G4 was approved by the FDA last July and has undergone a controlled U.S. rollout since that time. We continue to think Abbott’s multiyear lead in transcatheter mitral valve repair – G4 is its fourth-generation system – creates a high hurdle for competitive devices.”

First-in-class

For its part, Triclip, which is an adaptation of Mitraclip technology, just received a CE mark in August. The company presented at PCR on data from its TRILUMINATE CE Mark study. The 85-patient trial found that tricuspid regurgitation was reduced by 87.1%. All-cause mortality was 7.1% after a year. The study also found a positive impact on right ventricular function.

The TRILUMINATE pivotal trial is ongoing in the U.S. It is recruiting 700 patients and is expected to have primary endpoint data in August 2022.

With Tendyne, a transcatheter mitral valve replacement device, Abbott offered two-year follow-up data at PCR. The data show that the Tendyne system had eliminated MR in 93.2% of patients with significant improvements in quality of life and functional capacity at two years.

The implant received a CE mark in January. Abbott started an almost 1,000-patient U.S. pivotal trial for Tendyne in 2018, and pivotal data should be available by June 2022.

"Historically, people who were ineligible for standard-of-care surgeries to treat their mitral or tricuspid regurgitation were limited to symptom management, which does not address the underlying condition," summed up Paul Sorajja, the Headrick Family Chair of the Valve Science Center for the Minneapolis Heart Institute Foundation and director of the Center for Valve and Structural Heart Disease for the Minneapolis Heart Institute at Abbott Northwestern Hospital. "These devices treat extremely complex valve diseases that are debilitating and progress to very serious conditions when left untreated. The late-breaking data show significant and consistent reduction in regurgitation, allowing the heart valve to function as it is intended."

Abbott had a total of 11 late-breaker presentations at PCR e-Course, which also featured data for EU-marketed products, including the Amplatzer Amulet Left Atrial Appendage Occluder, a stroke prevention device, and the Portico transcatheter aortic valve replacement.

The former had a 99% implant success rate at one-year in a U.S. pivotal trial with a 3.5% rate of procedural complications, while the latter found that the new Flexnav delivery system improved its safety profile.

“Abbott is well-positioned to expand our leading positions due to the strength of our innovation around Mitraclip, tricuspid repair, mitral replacement, and the continued investment in transcatheter aortic replacement and structural interventions, such as left atrial appendage closure,” concluded Kokkinen. “We have proven experience building markets for emerging technologies in the cardiac space, as evidenced by Mitraclip, and are confident in the promise of our emerging and investigational technologies.”

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