The maker of the only FDA-approved temporary total artificial heart has opened an online store to take orders for the device and its accessories.
SynCardia Systems launched the site -- -- this week to make ordering the devices easier, faster, and more accurate, according to company spokesman Don Isaacs, who said some orders have already been placed.
"Because all the information is online, you are dealing with the current and correct information, so you don't have to worry about outdated forms or part numbers," he told 鶹ý.
Anyone can browse through the accessories on the website -- which include a shoulder bag, backpack, and car charger -- but patients need to have their SynCardia certified implant center order the products.
The "Medical Equipment" section of the site is not open for casual browsing -- you need to sign in with username and password, and to get those, you need to e-mail the company via a link on the shop "Contact Us" page. And only staff members at certified centers can order the device and the equipment needed to implant it.
The FDA-mandated certification process involves education about the surgery, a site visit to ensure that the center is equipped to perform the operation, supervision of the first implant, and training in patient discharge, all performed by SynCardia.
There are a few items on the site that are available for anyone to purchase -- cycling jerseys and shorts for Team SynCardia. They range in price from $97.50 to $116, with discounts if you purchase a complete "kit."
Wearing the gear has become popular among doctors who have been certified to implant the device, Isaacs said.
The temporary total artificial heart was approved by the FDA in 2004 as a bridge to heart transplantation, for use in the hospital.
More than 850 of the devices have been implanted, according to the company.
According to an FDA summary of the safety and efficacy data, overall survival in patients who received the device was 75.3%, 70.4%, and 67.9% at six, 12, and 24 months. More than three-quarters (79%) ultimately received a heart transplant.
Isaacs said that, in time, he expects the vast majority of centers implanting the device -- if not all of them -- will order through the website.