FDA's warning could impact global market for cardiovascular devices

Alexis Keenan
FILE - In this Jan. 28, 2009 file photo, scientist Andrea Ippolito prepares an experiment on the effect of drugs under consideration for use in drug-coated stents on cardiovascular cells, at the Boston Scientific Research and Development lab in Natick, Mass. If hospitals are the big winners of health reform, most analysts agree that medical device manufacturers appear to be the losers.  (AP Photo/Josh Reynolds, file)
In this Jan. 28, 2009 file photo, scientist Andrea Ippolito prepares an experiment on the effect of drugs under consideration for use in drug-coated stents on cardiovascular cells, at the Boston Scientific Research and Development lab in Natick, Mass. (AP Photo/Josh Reynolds, file)

The Food and Drug Administration sounded an alarm Thursday, publishing a notice that certain drug-coated stents and balloons used to treat coronary and peripheral artery disease could increase a patient’s risk of death after two years.

The warning is in the form of a notice to physicians, urging them to closely monitor patients with paclitaxel-coated balloons and paclitaxel-eluting stents.

“We are writing to inform you that the FDA is evaluating recent information regarding the potential for increased long-term mortality after use of paclitaxel-coated balloons and paclitaxel-eluting stents to treat peripheral arterial disease (PAD) in the femoropopliteal artery,” the January 17 notice states.

Coherent Market Insights told Yahoo Finance in an email that the global market for drug-eluting stents in 2018 was estimated at $2.26 billion and is expected to increase to $3.72 billion by 2026. In separately published reports Coherent’s valuation of the 2018 market was said to be $6.197 and projected it to surpass $9 billion by 2026, however Coherent said such reports, based on prior estimates, published its previous findings incorrectly.

J.P. Morgan Medtech Senior Analyst Robbie Marcus said the estimated global market for drug-eluting stents in 2018 was $3.6 billion, though the firm is waiting on final numbers from some drug-eluting stent companies. Marcus said J.P. Morgan forecasts market value at $3.45 billion for 2019, reaching $3.5 billion by 2023.

The global market for drug-eluting balloons, according to Marcus, is expected to reach $1.45 billion by 2020.

“None of these companies disclose to the sales level [for drug-eluting balloons] so it’s a little difficult to pull it out,” Marcus said.

Coherent Market Insights estimates the global drug-eluting balloon market, valued at $420 million in 2017, to increase to $843.2 million by 2026.

Major manufacturers of stent devices include Medtronic (MDT), Boston Scientific Corporation (BSX), Abbott Laboratories (ABT), AlviMedica, Amaranth Medical, Biosensors International Group, Bitronik, Lepu Medical Technology, Terumo Medical Corporation, Shandong JW Medical Systems, Stentys, Becton, Philips (PHG), Surmodics (SRDX), Cook Medical, HaangZhou HuaAn Biotechnology, XTENT, CARDINOVUM, Cardinal Health (CAH) (acquired Cordis), and Kyoto Medical Planning. Largest market share as of 2017 belonged to Boston Scientific (33%), Medtronic (32%) and Abbot (28%), according to Coherent.

Medtronic, Becton, Dickinson & Company (BDX) (acquired C.R. Bard), Boston Scientific Corporation, Cook Medical, B. Braun Melsungen AG, Philips, Opto Circuits Limited, Terumo Corporation, Surmodics, and Biotronik, are key manufacturers of drug-coated balloons. Coherent reports that as of 2017 Medtronic (57%) and Becton, Dickeson and Company (C.R. Bard) (40%) hold the largest shares of the market.

Asked how the FDA’s notice will impact the industry, Marcus said it will probably remain unknown until more market data is released. J.P. Morgan maintains business relationships with Medtronic and Becton, Dickinson & Company.

“There are going to be some hospitals that will stop using the devices until we get better clarity on the information and whether there truly is a mortality link to Paxitaxel,” he said. “There will be other institutions that will review some of the data out there, and see that there is one meta-analysis that had some flaws in it, that will wait for more conclusive evidence to do otherwise.”

Marcus also noted varying data between companies that manufacture similar devices.

“We saw Medtronic lowered forecasts a little bit at the J.P. Morgan healthcare conference recently, partly due to a slowdown in drug-coated balloon usage,” Marcus said. “On the flip side, we've had Becton, Dickinson at the same conference say that they are not seeing an impact in drug-coated balloon utilization.”

On Tuesday, Marcus said, Medtronic issued a presentation at a European conference showing patient level data disputing the meta-analysis suggesting a link to mortality for patients treated with drug-coated balloons.

According to a May 2018 report from Medical Device and Diagnostic, the average price of a coated balloon as of January 2018 was $1,500 — nearly 14 times that of a non-coated balloon, averaging $110.

Drug-eluting stents averaged around $1,000 in 2018, according to Marcus. Non-coated or bare metal stents average around $550.

The FDA cautions that patients treated with drug-coated balloons or drug-coated stents could face increased mortality, compared with patients treated with non-coated balloons or bare metal stents, respectively. The FDA’s warning is based on a meta-analysis of randomized trials, published in the Journal of the American Heart Association (JAMA).

Paclitaxel, and similar drugs originally used to treat various forms of cancer, are added to stent and balloon devices to treat patients with peripheral and coronary artery disease. Balloons are approved to treat peripheral artery blockage in the legs and arms. Stents are approved to treat artery blockage in the heart and peripheral arteries.

The idea behind coating stents and balloons with a drug is to prevent scar tissue by releasing medication over time. The drug prevents the body from producing its natural healing response to a foreign device, which is to create inflammation and scar tissue.

“The balloon and stent work to mechanically open the obstructed vessel. Paclitaxel is released from the balloon or stent to prevent scar tissue formation in the blood vessel that can re-obstruct the artery,” the FDA’s notice explains.

The FDA says it plans to evaluate long-term follow-up data to determine whether coated products cause long-term risks, including monitoring causes of death, dosage levels and patient characteristics. At the same time, the agency maintains that it currently believes the benefits of drug-coated stents and balloons outweigh risks when used as indicated.

Market research firm Global Market Insights predicts spurred market growth for coronary stents based on the American Heart Association’s reports showing that more than 90 million people in U.S. are impacted by heart disease.

This report, originally published January 22, was updated January 24 to include additional data from J.P. Morgan and revised guidance from Coherent Market Insights.

Alexis Keenan is a New York-based reporter for Yahoo Finance. She previously produced live news for CNN and is a former litigation attorney. Follow her on Twitter at @alexiskweed

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