Boston Scientific and Medtronic Reject Recent Study Showing Dangers of Their Paclitaxel Vascular Devices

Paclitaxel vascular devices

A recently published study by the Journal of the American Heart Association (JAHA) concludes that patients with certain drug-eluting vascular stents manufactured by Boston Scientific Corporation and Medtronic are at an increased risk of dying at two and five years following stent placement. Such an alarming analysis was rejected by both Boston Scientific and Medtronic who stand by their products, telling investors the products are safe and effective. The JAHA publication specifically states that “further investigations are urgently warranted.” As such, the publication is a message to Boston Scientific, Medtronic, and other manufacturers of similar drug-eluting devices that they should take measures to ensure their products are not placing patients at an unnecessary risk of suffering injuries or death.

What is a Drug-Eluting Stent?

Many patients in the United States suffer from coronary artery disease (CAD), a condition where a person’s coronary arteries are narrowed because of plaque buildup. Some patients take medications to treat CAD while others may undergo medical procedures, such as angioplasty and/or stent placement. One type of stent placement that is different and less-invasive than stent placement through coronary bypass surgery is drug-eluting stent placement in the groin or arm. One type of drug-eluting stent available to patients is coated with paclitaxel, a drug that is slowly released once the stent is implanted in the coronary artery. There are many types of drug-eluting stents, and the JAHA publication at issue addresses drug-eluting stents coated with paclitaxel as well as the balloons used when placing the stents and does not address other types of drug-eluting stents that do not involve the use of paclitaxel.

Further Studies Could Help Identify Potential Defects Associated with Certain Drug-Eluting Vascular Devices

The JAHA publication is raising concerns about a specific type of vascular medical device that is routinely used to treat coronary artery disease in some patients. The publication does not conclude that Boston Scientific and Medtronic’s devices are defective but simply sheds light on instances where patients have died following implantation of certain vascular stents. What Boston Scientific and Medtronic should do is not deny the conclusions of the JAHA publication, but instead review their own internal data to determine if there are any steps that can be taken to ensure patient safety. Undergoing further studies may help identify potential defects in their products, and such findings could ultimately save lives.

It is unfortunate that so many medical device manufacturers turn a blind eye to publications and data that do not reflect positively on their products. As such, many patients are injured or killed by medical devices that are not safe, especially for long-term use. When medical device manufacturers place dangerous products on the market, patients essentially act as guinea pigs, especially when medical devices enter the marketplace without having undergone any clinical studies on human beings. Injured patients and loved ones of deceased patients may wish to seek legal action to hold medical device manufacturers responsible for placing profit first over the safety of patients.

Contact Parker Waichman LLP Today to Schedule Your Free Case Evaluation

Injuries associated with a Boston Scientific or Medtronic paclitaxel-coated balloon (DCB) or stent used in the femoropopliteal artery to treat coronary artery disease can be devastating, especially if such injuries are fatal. If you have been affected by a paclitaxel-coated vascular device, you should consider acting quickly to speak with a Defective Medical Device Lawyer right away. At Parker Waichman LLP, our nationally-known lawyers focus their practice on helping victims injured by defective drugs and medical devices. Contact Parker Waichman LLP today to schedule your free case evaluation by calling (800) YOUR-LAWYER (1-800-968-7529).