Inspections, Compliance, Enforcement, and Criminal Investigations
Best Vascular Inc 3/11/09
Department of Health and Human Services
|Public Health Service
Food and Drug Administration
|9200 Corporate Boulevard
Rockville MD 20850
March 11, 2009
VIA FEDERAL EXPRESS
Mr. Krishnan Suthanthiran
Best Vascular, Inc.
7643 Fullerton Road
Springfield, Virginia 22153-2815
Re: Beta-Cath™ System
Dear Mr. Suthanthiran:
The Food and Drug Administration (FDA) has learned that your firm is marketing the BetaCath™ System in the United States (U.S.) for a new indication for use without marketing clearance or approval, in violation of the Federal Food, Drug, and Cosmetic Act (the Act).
The Office of Compliance (OC) in the Center for Devices and Radiological Health (CDRH) reviewed your firm's professional journal advertisement for the Beta-Cath™ System entitled "Intravascular Brachytherapy for the Treatment of Patients with Drug-Eluting Stent Restenosis: The RESCUE Registry." The American Journal of Cardiology, 2008 Nov 15;102(10): A5 (enclosed). Under section 201(h) of the Act, 21 U.S.C. 321(h), the Beta-Cath™System is a device because it is intended for use in the diagnosis of disease or other condition or in the cure, mitigation, treatment, or prevention of disease, or is intended to affect the structure or function of the body. The Act requires that manufacturers of devices that are not exempt obtain marketing approval or clearance for their products from the FDA before they may offer them for sale. This helps protect the public health by ensuring that new devices are shown to be both safe and effective or substantially equivalent to other devices already legally marketed in this country for which approval is not required.
A review of our records reveals that you have not obtained marketing approval or clearance before you began offering your product for sale, which is a violation of the law. The BetaCath™ System is adulterated under section 501 (f)(l)(B) of the Act, 21 U.S.C. 351(f)(l)(B), because you do not have an approved application for premarket approval (PMA) in effect pursuant to section 515(a) of the Act, 21 U.S.C. 360e(a), or an approved application for an investigational device exemption (IDE) under section 520(g) of the Act 21 U.S.C. 360j(g). The device is also misbranded under section 502(0) the Act, 21 U.S.C. 352(0), because you did not notify the agency of your intent to introduce the device into commercial distribution, as required by section 51O(k) of the Act, 21 U.S.C. 360(k). For a device requiring premarket approval, the notification required by section 51O(k) of the Act, 21 U.S.C. 360(k), is deemed satisfied when a PMA is pending before the agency. 21 CPR 807.81(b). The kind of information you need to submit in order to obtain approval or clearance for your device is described on the Internet at http://www.fda.gov/cdrhldevadvice/3122.html. The FDA will evaluate the information you submit and decide whether your product may be legally marketed.
Specifically, FDA approved your premarket approval application (PMA) for the Beta-Cath™ 5F System and your PMA supplements for the Beta-Cath™ 3.5F System, to "deliver beta radiation to the site of successful Percutaneous Coronary Intervention (PCI) for the treatment of in-stent restenosis in native coronary arteries with discrete lesions (treatable with a 20 mm balloon for the 30 mm and 40 mm Systems and injury areas up to 40mm for the 60 mm Systems) in a reference vessel diameter ranging from 2.7 mm to 4.0 mm." The professional journal advertisement references the RESCUE Registry and includes the statement that "[v]ascular brachytherapy as adjunct therapy to PCI for patients presenting with ISR of a DES, is safe and associated with low rates of recurrence and MACE. VBT appears to be superior in efficacy in comparison to repeat DES for ISR of DES and should be considered the therapy of choice for this difficult subset of patients."
The use of the Beta-Cath™ System for the treatment of in-stent restenosis in a drug-eluting stent (DES) represents a different patient population and, as a result, a different indication for use than the indication for use approved in your PMA and PMA supplements. The time course of vascular healing is fundamentally different between bare metal stents and drug-eluting stents. Specifically, at any time post-stent implantation, the cellular composition of the tissue within a drug-eluting stent is different than that within a bare metal stent. Therefore, patients presenting with in-stent restenosis within a drug-eluting stent are considered a different patient population than those patients presenting with in-stent restenosis within a bare metal stent. The clinical differences in the new (different) patient population raise new safety concerns, including the effect of radiation on the drug and polymer of the DES and the effect of radiation on the vessel wall that has been previously treated with an anti-proliferative drug. Because the above-referenced advertisement promotes the Beta-Cath™ System for a new indication for use that affects the safety or effectiveness of the device, you are required by section 515(d)(6) of the Act, 21 U.S.C.360e(d)(6), and 21 CFR 814.39(a)(l) to submit a PMA supplement to FDA for review and approval before making such a change.
You should take prompt action to correct these deviations. Specifically, FDA requests that you immediately cease dissemination of promotional materials for the Beta-Cath™ System that contain the new indication for use, as described above. Further information regarding the requirements for PMAs may be found at the FDA website at: http://www.fda.gov/cdrh/devadvice/pma/. Additional information about modifications to devices subject to premarket approval and the PMA supplement decision-making process, may be found at the FDA website at: http://www.fda.gov/cdrhlode/guidance/1584.html. The violations discussed in this letter do not necessarily constitute an exhaustive list. It is your responsibility to ensure that your labeling and promotional materials for the Beta-Cath™ System comply with each applicable requirement of the Act and FDA implementing regulations. Failure to promptly correct the violations discussed may result in regulatory action being initiated by the FDA without further notice. These actions include, but are not limited to, seizure, injunction, and/or civil money penalties. Also, Federal agencies are advised of the issuance of all Warning Letters about devices so that they may take this information into account when considering the award of contracts.
Please let this office know in writing what steps you have taken to correct these problems within fifteen (15) working days from the date you receive this letter. Please include a list of all labeling and promotional materials for your device, the same as or similar to those described above, and explain the steps you have taken to discontinue use of such materials. We also ask that you explain how you plan to prevent this from happening again. If you need more time, let us know why and when you expect to complete your correction. Please direct your response to Dorothy W. Lee, Acting Chief, Vascular & Circulatory Support Devices Branch, HFZ-341, Office of Compliance, at the Food and Drug Administration, 2098 Gaither Road, Rockville, Maryland 20850, facsimile at 240-276-0129.
Finally, you should understand that there are many FDA requirements pertaining to the manufacture and marketing of devices. This letter only pertains to the issue of premarket review for your device and your promotional material, does not necessarily address other obligations you have under the law.
Timothy A. Ulatowski
Office of Compliance
Center for Devices and