Allegations that Spectranetics Corp. violated federal laws in its importation and marketing of excimer lasers used in revascularization procedures have been settled, with the company agreeing to pay $5 million in civil penalties and forfeitures.

Spectranetics had allegedly “illegally imported unapproved medical devices and provided them to physicians for use in patients, conducted a clinical study in a manner that failed to comply with federal regulations, and promoted certain products for procedures for which the company had not received Food and Drug Administration approval or clearance,” according to a statement from the U.S. Attorney’s office in Denver, which led the investigation of the Colorado-based company.

Spectranetics manufactures and distributes excimer lasers and associated devices such as catheters and lead wires. The products are marketed for ablating occlusions of coronary arteries and vessels in the legs. It also sells other catheter devices for thrombus aspiration and to facilitate crossing of coronary and peripheral arterial blockages.

Among the specific charges: that the company “failed to meet its reporting obligations to FDA” regarding a study — called CORAL — of its products for ablating thrombi and atherosclerotic plaques in saphenous vein grafts.

Spectranetics described the CORAL study in a 2005 SEC filing as ongoing, but the company never mentioned it again in subsequent filings or news releases. It was a registry-based study of outcomes in some 150 patients undergoing laser therapy of degraded saphenous vein grafts.

Under the agreement with prosecutors, no criminal charges will be filed and the company’s products will remain on the market. Spectranetics will pay $4.9 million to the federal government in civil damages and will forfeit $100,000 in cash or property, according to the company.

A Spectranetics statement quoted the firm’s president as saying he was pleased to have resolved the issues raised by the government.

A report broadcast during the CBS Evening News on June 8 noted that one in 200 patients die during elective coronary angioplasty procedures and suggested that patients may be safest at institutions where surgical backup is readily available when complications occur. The report also noted that as many as 40 percent of the angioplasties performed may be unnecessary because patients could experience the same benefits from drug therapies.

Coronary angioplasty is widely practiced and is also known as percutaneous coronary intervention, or PCI. The procedure is minimally-invasive and performed both in emergency situations and on an elective basis. During PCI, interventional cardiologists thread a catheter up through a small incision in a patient’s groin or wrist into the coronary artery. There, they inflate a surgical balloon to clear away plaque blockages and insert stents to keep arteries open.

Michael Ragosta, M.D., Director of Cardiac Catheterization Laboratories and Director of Interventional Cardiology at the University of Virginia Health System, recommends that patients considering elective angioplasty do their homework before deciding to proceed. “Make sure you know if medications or other therapies would work just as well for you, and find out about your hospital’s PCI mortality rates, PCI experience levels and surgical back-up capabilities,” he says. “Do your best to learn about the risks and benefits of this procedure. Make the most informed decision possible.”

Ragosta offers the following information about UVA’s PCI results, experience and surgical backup capabilities:

PCI mortality

UVA recognizes the potential overuse of PCI and make every effort to be sure patients are likely to benefit before inserting stents. It has one of the nation’s lowest mortality rates for PCI overall (elective, urgent and emergent PCI) mortality is only 0.67%, which is in the 84th percentile (with 100 being the highest) according to national benchmarking provided by the American College of Cardiology/NCDR).

Experience

UVA performs over 600 PCI procedures each year and, on average, its interventional cardiologists perform more than 75 cases a year. Studies have shown that patients undergoing procedures performed by low volume operators (<75 cases per year) at low volume institutions (<200 angioplasties per year) do not do as well as those who receive procedures performed by a high volume operator at a high volume institution.

In addition, UVA’s interventional cardiologists are recognized as national leaders in techniques such as fractional flow reserve and non-invasive imaging that have been proven to help optimize management decisions regarding angioplasty, thus minimizing unnecessary procedures.

On-site surgical backup

The issue of on-site surgical backup is an area of debate in cardiology. At the present time, the major professional societies including the American Heart Association, the American College of Cardiology and the Society for Cardiovascular Angiography and Intervention only recommend the performance of elective angioplasty at institutions with surgical backup. Although the need for emergency surgery is low (about 2-3 per 1,000 interventions), it remains unpredictable. Delays in transferring a patient after a failed angioplasty to an institution with bypass surgery capabilities can lead to a fatal outcome. It is important for prospective patients to understand the potential risks of undergoing PCI at an institution without surgical backup.

Source: University of Virginia Health System