FDA Medical Device Warning

03/30/2019

On the Safety Front:

FDA Probe Is Rocking These Medical Device Makers

A Food and Drug Administration probe into chemotherapy drug paclitaxel is making waves for medical device companies SurModics (SRDX), Boston Scientific (BSX), Medtronic (MDT) and Becton Dickinson (BDX).

The FDA said paclitaxel-coated medical devices may have led to an increase in patient deaths, but the FDA concerns stem from an analysis of five years' worth of data in patients with peripheral artery disease.

In peripheral artery disease, the arteries of the legs, stomach, arms and head narrow, slowing blood flow. Medical device companies make "balloons" and stents to mechanically reopen the arteries. Then, the device releases paclitaxel to keep scar tissue from forming, which could re-block the artery.

The FDA recommends that physicians seek alternatives to these paclitaxel-tied medical devices in patients with peripheral artery disease. This is bad news for SurModics, in particular, as it begins tests of its drug-coated balloon, Needham analyst Mike Matson said.

The FDA examined three clinical studies with five-year follow-up data for a total of 975 patients. Researchers found a 50% increase in the risk of death in the group of patients treated with paclitaxel medical devices.

At the five-year mark, there was a 20.1% risk of death for the paclitaxel group vs. a 13.4% risk for the control group. The FDA noted researchers still aren't sure what caused the increase in death. The agency has said paclitaxel-coated balloons and stents can improve blood flow and decrease the likelihood for repeat procedures.  However, because of this concerning safety signal, alternative treatment options should generally be used for most patients while long-term mortality is evaluated

Alternatives In Peripheral Artery Disease

The FDA's recommendation pertains only to patients with peripheral artery disease. This group of patients can also be treated with plain balloons, bare metal stents and atherectomy. In the latter procedure, a doctor uses a catheter and sharp metal blade to remove arterial plaque.

SurModics is studying its paclitaxel-coated balloon in patients with peripheral artery disease. The test, called Transcend, pits SurModics' medical device against one from Medtronic.  FDA Committee To Discuss Medical Devices

An FDA advisory committee plans to weigh the benefits vs. the risks of these medical devices at a future meeting.    Eluvia is a drug-eluting stent that uses paclitaxel. Last September, the FDA approved Eluvia in peripheral artery disease.

Medtronic's In.Pact Admiral is a paclitaxel-coated balloon catheter used by pushing through the skin. Physicians use it to treat lesions in the superficial femoral or popliteal arteries.

Becton Dickinson is working on a drug-coated balloon called Lutonix to treat blocked arteries below the knee. Evercore's Kumar notes that the medical device company expected approval in mid-2019, but likely must wait for approval after the advisory committee meeting.


https://www.fda.gov/MedicalDevices/Safety/LetterstoHealthCareProviders/ucm633614.htm?utm_campaign=FDA+MedWatch+Paclitaxel-Coated+Balloons+and+Paclitaxel-Eluting+Stents&utm_medium=email&utm_source=Eloqua