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A US company claims to have received federal approval to market a 9-mm handgun as a medical device and hopes the US government will reimburse seniors who buy the $300 firearm. But the US Food and Drug Administration says there are currently no formal designations of the gun as a medical device.
Called the , the weapon is designed for people who have trouble firing a normal handgun due to arthritis and other debilitating conditions.
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鈥淚t鈥檚 something that they need to assist them in daily living,鈥� says Matthew Carmel, president of in Maplewood, New Jersey, which hopes to manufacture the Palm Pistol 鈥� now just a patent and specifications.
鈥淭he justification for this would be no more or less for a [walking aid] or wheelchair, or any number of things that are medical devices,鈥� he says.
The sales information reads: 鈥淚t is also ideal for seniors, disabled or others who may have limited strength or manual dexterity. Using the thumb instead of the index finger for firing, it significantly reduces muzzle drift, one of the principal causes of inaccurate targeting. Point and shoot couldn鈥檛 be easier.鈥�
Constitutional Arms informed a that the FDA had approved the Palm Pistol as a medical device, classifying it as a 鈥淒aily Activity Assist Device鈥�.
The company reportedly said that they are now seeking a coding for the gun, which if awarded would allow it to be prescribed and reimbursement paid through Medicare or private health insurance.
Health benefits?
But FDA spokeswoman Siobhan DeLancey denies that the agency has formally labelled the gun a medical device: 鈥淎t this time, there have been no formal designations of the Palm Pistol by the FDA as a medical device.鈥�
鈥淭he FDA doesn鈥檛 make a determination about a weapon, they make a determination about medical products that are designed to help people and improve their health,鈥� says , Director of the Medical Device Safety Institute at Beth Israel Deaconess Medical Center in Boston.
Carmel contends that he submitted documentation to the FDA to get Palm Pistol listed as a Class I medical device 鈥� a classification reserved for devices that pose little risk to a patient鈥檚 health, such as stethoscopes and walking aids.
Registration doubts
As evidence of the government鈥檚 stamp of approval, Carmel points to a he received from FDA.
Dated 2 December 2008, it reads: 鈥淵ou have successfully entered your facility registration and device listing information,鈥� then goes onto list an address in Maplewood, New Jersey, for Constitution Arms.
鈥淚 see that a facility has been registered. That does not register a device or a pistol,鈥� Maisel says.
Even if the FDA were to approve the Palm Pistol as a medical device, securing Medicare reimbursement is another issue entirely, says , an expert on medical device regulation at Duke University Medical Center in Durham, North Carolina. 鈥淢edicare does not cover everything that FDA approves.鈥�
鈥楴ice gimmick鈥�
To reimburse a drug, treatment or device, Medicare must determine that it is reasonable and necessary in the course of medical treatment, he says. 鈥淭he first question for Medicare is whether this would be potentially beneficial, and the answer seems to be obviously no.鈥�
Constitution Arms is taking pre-orders for the Palm Pistol, while Carmel determines whether the market is large enough to go into production. 鈥淚鈥檝e been getting a lot of calls,鈥� he says.
For $25, customers can be one of the first to own the weapon, which Carmel expects to deliver by 2010. The refundable deposit will sit in an account and serve as proof to investors that the Palm Pistol has a sizeable market, he says.
The potential for Medicare reimbursement, and perhaps even payment from private insurers will also encourage investors.
鈥淚t鈥檚 not implanted in the body, but the obvious result of this thing [a bullet] could be,鈥� says Schulman.
鈥淚t鈥檚 a nice gimmick for this manufacturer, but I can鈥檛 imagine that Medicare would pay for this, since it doesn鈥檛 meet their criteria,鈥� he says. 鈥淭hey鈥檙e trying to game the system, clearly, but hopefully they won鈥檛 get much further.鈥�
