Friday Five - The medtech week in review

Medtech’s No. 1 admits PAD data omission; but rallies on earnings beat

Medtronic at the end of last week admitted a programming error had led to the omission of mortality data in the statistical analysis of two- and three-year follow-up results of the ongoing IN.PACT Global post-market study. The company’s IN.PACT Admiral is one of the leading brands of paclitaxel-coated balloons used to treat peripheral artery disease, and the news comes at a time where a debate is raging over a potential higher mortality risk linked to these devices, as a meta-analysis by Katsanos et al found in December.

Adding fuel to the fire is a notice, issued four days after Medtronic’s omission admission, in the journal Circulation pointing to a serious mistake in the reported five-year mortality rates in a study comparing Cook Medical’s Zilver PTX drug-coated stent for PAD against standard balloon angioplasty.

[See The Wider View: Oops, they did it again - could Cook Medical, Medtronic mortality data slip-ups weaken paclitaxel-in-PAD standing?]

Medtronic’s top executives did not mention anything about the data error when discussion the company’s third fiscal quarter results; instead, attention was focused on the firm having turned in another solid performance and beating expectations again. Heartened by its results, Medtronic raised its revenue and earnings guidance for the full fiscal 2019, which ends April 30. The company attributed the growth to a strong performance from its minimally invasive therapies and restorative therapies business groups, which help offset weakness in its cardiovascular unit. Diabetes, which had been reporting double-digit growth of over 20 percent since Q4 FY2018, posted a much more modest sales increase of 6 percent. Medtronic’s executives pointed out that this was largely due to difficult year-on-year comparisons, and that this will continue to impact diabetes’ Q4 sales, before normalising in fiscal 2020.

[See The Wider View: Diabetes still Medtronic’s rising star, not fallen angel]


Abbott teams up to push digitalisation of diabetes solutions

Abbott, which saw diabetes care sales jump 28 percent on the back of ongoing strong market adoption of its FreeStyle Libre continuous glucose monitoring system, has teamed up with Novo Nordisk to enhance the digital features of this product. In this non-exclusive partnership, Abbott will integrate insulin dose data from Novo Nordisk's pre-filled and durable connected pens directly into the digital health tools compatible with Abbott's FreeStyle Libre system, including the FreeStyle LibreLink mobile app. The app is an integral component of the diabetes management solution that Abbott is building around FreeStyle Libre; it allows the patient to just wave their smartphone over the glucose sensor that is worn on the back of their upper arm, and get real time readings of their glucose levels, as well as assess their glucose history over a time period.

The addition of insulin dosing data from the connected pens is expected to streamline the day-to-day processes for managing the patient's blood glucose levels.


US reimbursement - albeit with caveats - finally here for LivaNova's neurostim tech for depression

Over a decade after the US Centers for Medicare and Medicaid denied reimbursement coverage for LivaNova's vagus nerve stimulation (VNS) system for use on treatment-resistant depression (TRD) patients, the agency has agreed to fund the therapy for this indication within its Coverage with Evidence Development framework.

The conditions for coverage entail LivaNova conducting a randomised, controlled trial of VNS therapy in TRD patients, with a one year follow-up; CMS will pay for the therapy in patients enrolled in this study. Additionally, the agency agreed to reimburse replacement systems for TRD patients that have already received the VNS system.

In spite of the caveats attached to the reimbursement decision, this represents a significant opportunity for LivaNova and widens the door for the adoption of its VNS therapy for this indication.

[See The Wider View: LivaNova investors get happy on final CMS decision on vagus nerve stim for depression]


EU approval for PASCAL comes early for Edwards Lifesciences; but Abbott litigation cloud looms  

Edwards Lifesciences announced this week that it has CE marked its PASCAL transcatheter mitral valve repair system. The EU authorisation comes three months earlier than expected and sent shares in the company rallying to a 52-week high. PASCAL was highlighted by the company as one of its key growth drivers, especially as the mitral valve opportunity remains largely untapped; however, Edwards is facing a likely lengthy legal battle against Abbott, who filed a mitral valve patent infringement complaint against the company in several jurisdictions. Abbott's MitraClip has been available in Europe since 2008 and it has monopoly in the US market. It is seeking to block Edwards from selling PASCAL; Edwards has not commented on how this patent litigation will impact its launch plans for PASCAL.

[See The Wider View: Earlier-than-expected PASCAL CE mark not necessarily a boon for Edwards Lifesciences]


NeoVasc settles with Micro Interventional Devices to resolve mitral valve wrangle

While the legal tussle between Edwards and Abbott has just begun, another mitral valve-related lawsuit was resolved. NeoVasc, developer of the Tiara device, agreed to settle its dispute with Micro Interventional Devices (MID), which is developing the Permavalve system. MID had filed a complaint in New Jersey in September last year against Neovasc over alleged patent infringement. Under the terms of the agreement, Neovasc will pay MID settlement fees totalling $3 million, in installments over the next 2.5 years. Additionally, Neovasc will pay MID a royalty of 1.3% on annual net sales of the Tiara. The agreement includes buy-out clauses that allow Neovasc, or an acquirer of Neovasc or the Tiara assets, to buy-out these royalty obligations.


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