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American Morning
House Call: Faulty Heart Devices
Aired June 13, 2003 - 07:45 ET
THIS IS A RUSH TRANSCRIPT. THIS COPY MAY NOT BE IN ITS FINAL FORM AND MAY BE UPDATED.
THIS IS A RUSH TRANSCRIPT. THIS COPY MAY NOT BE IN ITS FINAL FORM AND MAY BE UPDATED.
DARYN KAGAN, CNN ANCHOR: Health news for you now. A California company that makes surgical devices to treat heart aneurysms has admitted to hiding potentially failed defects about its product.
Our medical correspondent, Dr. Sanjay Gupta, is at CNN Center in Atlanta with details in our morning "House Call."
Sanjay -- good morning.
DR. SANJAY GUPTA, CNN MEDICAL CORRESPONDENT: Good morning, Daryn.
A couple of important medical stories we're following this morning. The company you're referring to, Endovascular Technologies. They're out of Menlo Park. They're actually a subsidiary of a larger corporation known as Guidant Corporation.
This has been a company that's been around for quite some time. Let's take a look at the history of this particular device, and I'll tell you a little bit more about what the device does.
Originally, it was actually approved in 1999. In March of 2001, just one year later, the product that we're talking about underwent a voluntary recall. Four months later, it was reintroduced. About 18,000 patients now have this particular device.
Now, the device is actually used to treat aneurysms, as you said. At issue are 10 felonies that the company has now pleaded guilty to, charges of shipping misbranded products and making false statements to the government about the safety of the product. This may have resulted in 2,600 different complications, 12 deaths, and that's certainly what's at issue here.
The company was asked about this, and this is what they had to say about the 18,000 people or so that have the product now: "No patient with the ancure endograft implant is at risk as a result of this matter, and the implant continues to demonstrate excellent long- term clinical results."
This is an implant, Daryn, that's used to treat aneurysms. Specifically what happens is if a patient has an aneurysm in a blood vessel, this particular graft is a tube that actually goes inside the blood vessel almost as another tube to try and prevent that aneurysm from growing, or more importantly, from rupturing.
Again, as you saw from the company there, it appears that this particular device in the people that already have it, the 18,000 or so, it should not present any complications. The best bet if you do have this device or you know somebody who has the device, go ahead and check with your doctor. You may need to get an x-ray to find out the location of the device to make sure that it hasn't moved or anything.
Also, Daryn, coming up in the next hour, were going to talk about something very interesting in the world of surgery, doing operations on people while they're awake. It's becoming more and more common. You're not going to believe the sorts of operations that people undergo while awake. Now, we'll have that in about an hour -- Daryn.
KAGAN: We will forward to that; also look forward to hearing how you, yourself, have done some operations recently with your patients.
GUPTA: I'll give you some stories, absolutely.
KAGAN: All right, have you got some stories.
GUPTA: All right.
KAGAN: All right, Sanjay, thank you.
TO ORDER A VIDEO OF THIS TRANSCRIPT, PLEASE CALL 800-CNN-NEWS OR USE OUR SECURE ONLINE ORDER FORM LOCATED AT www.fdch.com.
Aired June 13, 2003 - 07:45 ET
THIS IS A RUSH TRANSCRIPT. THIS COPY MAY NOT BE IN ITS FINAL FORM AND MAY BE UPDATED.
DARYN KAGAN, CNN ANCHOR: Health news for you now. A California company that makes surgical devices to treat heart aneurysms has admitted to hiding potentially failed defects about its product.
Our medical correspondent, Dr. Sanjay Gupta, is at CNN Center in Atlanta with details in our morning "House Call."
Sanjay -- good morning.
DR. SANJAY GUPTA, CNN MEDICAL CORRESPONDENT: Good morning, Daryn.
A couple of important medical stories we're following this morning. The company you're referring to, Endovascular Technologies. They're out of Menlo Park. They're actually a subsidiary of a larger corporation known as Guidant Corporation.
This has been a company that's been around for quite some time. Let's take a look at the history of this particular device, and I'll tell you a little bit more about what the device does.
Originally, it was actually approved in 1999. In March of 2001, just one year later, the product that we're talking about underwent a voluntary recall. Four months later, it was reintroduced. About 18,000 patients now have this particular device.
Now, the device is actually used to treat aneurysms, as you said. At issue are 10 felonies that the company has now pleaded guilty to, charges of shipping misbranded products and making false statements to the government about the safety of the product. This may have resulted in 2,600 different complications, 12 deaths, and that's certainly what's at issue here.
The company was asked about this, and this is what they had to say about the 18,000 people or so that have the product now: "No patient with the ancure endograft implant is at risk as a result of this matter, and the implant continues to demonstrate excellent long- term clinical results."
This is an implant, Daryn, that's used to treat aneurysms. Specifically what happens is if a patient has an aneurysm in a blood vessel, this particular graft is a tube that actually goes inside the blood vessel almost as another tube to try and prevent that aneurysm from growing, or more importantly, from rupturing.
Again, as you saw from the company there, it appears that this particular device in the people that already have it, the 18,000 or so, it should not present any complications. The best bet if you do have this device or you know somebody who has the device, go ahead and check with your doctor. You may need to get an x-ray to find out the location of the device to make sure that it hasn't moved or anything.
Also, Daryn, coming up in the next hour, were going to talk about something very interesting in the world of surgery, doing operations on people while they're awake. It's becoming more and more common. You're not going to believe the sorts of operations that people undergo while awake. Now, we'll have that in about an hour -- Daryn.
KAGAN: We will forward to that; also look forward to hearing how you, yourself, have done some operations recently with your patients.
GUPTA: I'll give you some stories, absolutely.
KAGAN: All right, have you got some stories.
GUPTA: All right.
KAGAN: All right, Sanjay, thank you.
TO ORDER A VIDEO OF THIS TRANSCRIPT, PLEASE CALL 800-CNN-NEWS OR USE OUR SECURE ONLINE ORDER FORM LOCATED AT www.fdch.com.
