This means that they may be used for shallow-water activities like swimming in a pool or ocean. Apple Watch Series 8 and Apple Watch SE have a water resistance rating of 50 meters under ISO standard 22810:2010.iPhone activation required on iPhone purchases made at an Apple Store with one of these national carriers: AT&T, Sprint, Verizon, or T‑Mobile. ACMI is not available for purchases made online at the following special stores: Apple Employee Purchase Plan participating corporate Employee Purchase Programs Apple at Work for small businesses Government, and Veterans and Military Purchase Programs, or on refurbished devices. See the Apple Card Customer Agreement for more information. Taxes and shipping are not included in ACMI and are subject to your card’s variable APR. If you choose the pay‑in‑full or one‑time‑payment option for an ACMI‑eligible purchase instead of choosing ACMI as the payment option at checkout, that purchase will be subject to the variable APR assigned to your Apple Card. Variable APRs for Apple Card other than ACMI range from 13.99% to 24.99% based on creditworthiness. See /kb/HT211204 for more information about eligible products. to select at checkout for certain Apple products purchased at Apple Store locations,, the Apple Store app, or by calling 1-800-MY-APPLE and is subject to credit approval and credit limit. Last month, Cardiac Dimensions made a serious play for FMR and announced it raised $39 million to build strong clinical evidence for its Carillon Mitral Contour System.Apple Card Monthly Installments (ACMI) is a 0% APR payment option available only in the U.S. Edwards gained access to Cardioband through its $340 million plus milestone payments acquisition of Valtech Cardio Ltd. Irvine, CA-based Edwards competes in the FMR market with the Cardioband device. The company completed its clinical trial for this indication and it is speculated the firm could present data at the upcoming Transcatheter Cardiovascular Therapeutics meeting in September. Really what we’re looking to do is target that big clinical gap between a CRT and a transplant.”Īncora Heart could face off against stiff competition in the FMR market.Ībbott is seeking to gain FDA approval for an FMR indication for its MitraClip. You have this long kind of clinical chasm or gap before you end up with an LVAD or a transplant. “And after that you’re really out of options for a heart failure perspective. “When you think about the heart failure treatment algorithm, patients get on medical therapy and eventually if it’s required they’ll have a CRT,” he said. The company could file for a pivotal IDE sometime in 2019. “Not too far after that, we’ll submit another protocol to FDA focusing on patients who have had a prior mitral valve intervention that’s reoccurred because the left ventricle had to continue to dilate.” “We’ll be submitting an additional protocol to FDA very shortly that will focus on heart failure,” Closs said. The company said early findings show Ancora Heart’s technology could have some benefit for treating heart failure patients. is to continue to enroll in that study, which the primary endpoint or primary completion is FMR,” Closs said. The device can realign the geometry of the valvular apparatus, so it can function more efficiently. Our approach is to target the fundamental cause of FMR, which is a dilated dysfunctional left ventricle.”AccuCinch is a transfemoral access catheter-based approach. “In the traditional FMR market technology is all focused on the valve, and we know the fundamental problem is the left ventricle is dilated and it has changed the geometry of the valve. “The AccuCinch System is a left ventricular repair technology and it really is a new category and class of therapy,” Jeff Closs, president and CEO of Ancora Heart, told MD+DI. Ancora Heart said it can now enroll a second group of patients and expand to 15 heart centers across the U.S. The Santa Clara, CA-based company came closer to its goal to participate in the market after it received FDA approval to expand the enrollment for an early feasibility study of the AccuCinch. Ancora Heart said FDA has approved an expansion of the company’s feasibility study to evaluate the AccuCinch Ventricular Repair System designed for the treatment of heart failure and functional mitral regurgitation (FMR).Īncora Heart is making a play for the functional mitral regurgitation (FMR) treatment market – which is currently populated by medtech juggernauts Abbott Laboratories and Edwards Lifesciences.
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