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BD Remains Confident About LUTONIX DCB Despite FDA Letter

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Becton, Dickinson and Company (BDX - Free Report) , popularly known as BD, announced that it has received a ‘warning’ letter from the FDA on Mar 15, 2019, regarding the increased long-term mortality of its LUTONIX drug-coated balloon (“DCB”). Notably, the FDA’s concern follows a solid preliminary analysis of long-term data of the LUTONIX DCB.

BD’s flagship LUTONIX DCB is a paclitaxel-coated device that is used to treat peripheral arterial disease in the femoropopliteal artery. Following the news release, the share price of BD inched down 1.8% yesterday. The stock has a Zacks Rank #3 (Hold).

Three Major Factors Supporting BD

Per the recent press release issued by BD, it seems that the company is still optimistic about the LUTONIX DCB. Here’s Why:

Favorable Pre-clinical and Clinical data

Investors should notice that BD has issued a statement indicating the “robustness of its pre-clinical and clinical data” of LUTONIX DCB. Management at BD claims to have evidence from seven separate studies that successfully demonstrated the safety and efficacy of these products.

This apart, BD has analyzed and reviewed all available data about the LUTONIX DCB over the past several months, all of which had favorable outcomes.

The LEVANT 2 study

BD conducted a LEVANT 2 study to evaluate the possibilities of the long-term mortality risks of LUTONIX DCB. The study enrolled 1,189 patients — a sample that is significantly more than the pooled dataset by the FDA. BD confirmed that the company did not witness any abnormalities or an indication of long-term mortality in this large patient cohort.

Underlying Cause Not Mentioned by the FDA

Interestingly, the FDA has accepted that the underlying cause pertaining to the increased risk of mortality for LUTONIX DCB is yet to be decoded. In fact, the amount of long-term data analyzed by the FDA was also limited, which might have created inconsistency in estimating mortality risk. Further, the data was not intended to be pooled.

Collaborations With Other Global Regulators

BD is trying to collaborate with global regulators, academic societies and other thought leaders to support an independent patient-level meta-analysis and further investigate the importance of safety and DCBs. Furthermore, the company added that it is currently working with the FDA and VIVA Physicians Group.

BD plans to complete these independent investigations before the FDA's Advisory Committee Meeting (panel) that is anticipated to take place in mid-June 2019.

Key Picks

A few better-ranked stocks from the MedTech space are DexCom, Inc. (DXCM - Free Report) , Varian Medical Systems, Inc. (VAR - Free Report) and Masimo Corporation (MASI - Free Report) , each carrying a Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.

DexCom delivered a positive earnings surprise in each of the trailing four quarters, the average being 132.3%.

Varian Medical has a long-term earnings growth rate of 8%.

Masimo Corporation has a long-term earnings growth rate of 15.6%.

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