05.10.12
A U.S. Food and Drug Administration (FDA) advisory panel voted on April 25 to recommend the approval of the Ventricular Assist System from HeartWare International Inc.
The agency’s Circulatory System Devices panel voted 9-2 to recommend approval of the company’s experimental left ventricular assist device (LVAD) as a bridge to heart transplantation for patients with end-stage heart failure. The 11-member panel agreed unanimously that the new device is effective. The group wasn’t as harmonious about the device’s safety, but voted 8-3 that the device was safe.
Heart failure is a progressive disease that strikes one in five Americans older than 40. It occurs when a damaged organ can’t supply enough oxygen-rich blood to keep other organs, such as the lungs, working. There are few treatments and no cure.
Prior to the panel meeting, the FDA issued a report noting that though some questions remained about missing data for patients that tested the system, the device “seems to have statistically met the primary endpoints.” FDA staff also expressed concern about stroke rates, according to agency documents.Fifteen patients on the HeartWare device experienced clotting and stroke about six months into testing, according to the FDA’s report. Agency staff said this suggests a trend toward higher stroke rates with the pump compared to other devices. If the device is approved, HeartWare most likely will have to conduct a post-approval study on the safety and effectiveness of the device by body surface area and quality of life five years after the date of implant. An agency representative told the panel the FDA was interested in “rigorous” post-approval data.
HeartWare’s device already has been approved in Europe.
Of the nearly 140 patients who used HeartWare’s device in the final-phase trial (called ADVANCE), 90.7 percent survived, according to the company. This is compared with 90.1 percent of 499 patients in a registry for patients who use mechanical circulatory support for advanced heart failure, such as the HeartMate II, made by Pleasanton, Calif.-based Thoratec Corp. This is the first LVAD trial to use a registry as a control arm—which broke new ground as far as what the FDA accepts for trial data. The primary endpoint of the trial was being alive after 180 days, or receiving a transplant. Panelists struggled with determining what sort of safety comparisons could be made between the HeartWare and registry arms of the trial— particularly when comparing stroke rates between HeartWare patients and the control group. The HeartMate II VAS is surgically implanted in an abdominal pouch, and the HeartWare VAS is implanted next to the heart.
Eleven patients who received the HeartWare device had an ischemic stroke within 180 days (27 percent of whom died or else were no longer eligible for a heart transplant) and four patients died of a hemorrhagic stroke. But whether 11 ischemic strokes is a high or low number is unclear, because stroke data wasn’t tracked in the registry. One panelist suggested 11 strokes is not a lot, especially given the alternative of not getting an LVAD, which for most patients would mean death. There were six deaths in the HeartWare group, three of which appeared to be related directly to the device. Still, the death rate was lower in the HeartWare group than in the registry group (4.3 percent compared to 8.8 percent).
Despite gaps in safety data, panelists seem to feel that another bridge-to-transplant LVAD option should be available for critically ill patients.
“I think this device is of incredible benefit to patients who are very ill,” said panelist Ralph Brindis, M.D., a cardiologist at Oakland Kaiser Medical Center in Oakland, Calif.
The U.S. market for left ventricular pumps may pass $750 million in 2015, Jason Mills, an analyst with Canaccord Adams Inc. in San Francisco, Calif., told Bloomberg news. Mills said if HeartWare’s product is approved for heart-failure patients who aren’t eligible for a transplant, the company may split the U.S. market with HeartMate II within the next three years. Thoratec currently dominates the worldwide ventricular assist device market with about 68 percent of the market share, according to data compiled by Bloomberg analyst Michael Manns. HeartMate had $366 million in revenue last year.
HeartWare currently is recruiting patients for a study on the device’s use in patients who aren’t eligible for a heart transplant, according to the National Institutes of Health website, clinicaltrials.gov.
Acting panel chair, Richard Page, M.D., a professor at the University of Wisconsin School of Medicine and Public Health, called the HeartWare device “a real advance in technology” but said the ADVANCE trial was poorly conducted—“a mess,” he called it.
“We are pleased with the panel’s strong recommendation and would like to thank them for their thoughtful review of the data presented from the ADVANCE study,” said Doug Godshall, CEO and president of Framingham, Mass.-based HeartWare. “The Advisory Committee meeting outcome represents an important step toward approval of the HeartWare Ventricular Assist System in the United States, and we look forward to continuing our dialogue with the FDA as it finalizes its review of our PMA (premarket approval application). HeartWare remains committed to optimizing outcomes for patients with end-stage heart failure and looks forward to expanding the clinical experience for the device in the future.”
HeartWare originally submitted its PMA to the FDA in 2010.
Danielle Antalffy, an analyst with Boston, Mass.-based Leerink Swann, predicted in a note that FDA approval could be delayed until late fourth quarter of 2012 while the agency collects more information on the sintered HVAD—the small implantable centrifugal blood pump located at the center of the HeartWare device. Sintering titanium is a process by which minute beads are metallurgically affixed to a titanium surface; the practice commonly is used in medical devices to facilitate tissue adhesion at the sintered region. Sintering of the HVAD pump on the outer surface of the implanted inflow tube is designed to promote tissue in-growth on the lower section of the inflow tube. More time will allow increased data to be available from ongoing continued access protocol patient enrollment. Antalffy and colleagues previously had predicted a third-quarter approval.
The FDA is not bound by its advisory panel recommendations, but it usually follows them.
AdvaMed’s New Chairman Outlines Group’s Three-Year Advocacy Plan
The Advanced Medical Technology Association (AdvaMed), held a conference call recently with the group’s new chairman of the board David Dvorak, CEO of Zimmer Holdings Inc. Dvorak began the call by giving a rundown of his vision for the association for the next three years.
Dvorak is no stranger to the Washington, D.C.-based industry trade group. He has served AdvaMed in various capacities during the past 10 years. He has been an active member of the board since 2006 and has served as chairman of the association’s orthopedics sector since 2004. For the past two years he chaired AdvaMed’s Payment & Health Care Delivery Committee, where he led the association’s
efforts to ensure that new payment delivery programs—such as accountable care organizations and bundling systems—support medical innovation and preserve patient/physician choice.
He highlighted the importance of:
He then articulated his intent for the association to:
Dvorak said it was particularly important to “move beyond the beltway (the highway that surrounds Washington, D.C.) and listen to patients to better understand what they need.”
When asked, Dvorak clarified that these goals are extensions of what already is in place within AdvaMed, rather than brand new initiatives. He also said that any new in-house research will be made as public as possible in the interest of transparency.
Dvorak expressed a sense of unity with the global medtech industry.
“All governments are facing the same problems,” he said. “Aging populations, chronic disease, economic issues. I see the medical technology industry as a solution as it promotes public health.”
User Fee Inches Closer to Reauthorization
During its mark-up session on April 25, the Senate’s Health Education and Labor Committee voted to move the U.S. Food and Drug Adminstration’s user fee reauthorization legislation to the U.S. Senate floor for a full vote. A mark up also was scheduled in the U.S. House of Representatives, but has been delayed (and was not held as of press time). The delay could be due to squabbling between Democrats and Republicans about medical device approval language.
The agency’s Circulatory System Devices panel voted 9-2 to recommend approval of the company’s experimental left ventricular assist device (LVAD) as a bridge to heart transplantation for patients with end-stage heart failure. The 11-member panel agreed unanimously that the new device is effective. The group wasn’t as harmonious about the device’s safety, but voted 8-3 that the device was safe.
Heart failure is a progressive disease that strikes one in five Americans older than 40. It occurs when a damaged organ can’t supply enough oxygen-rich blood to keep other organs, such as the lungs, working. There are few treatments and no cure.
Prior to the panel meeting, the FDA issued a report noting that though some questions remained about missing data for patients that tested the system, the device “seems to have statistically met the primary endpoints.” FDA staff also expressed concern about stroke rates, according to agency documents.Fifteen patients on the HeartWare device experienced clotting and stroke about six months into testing, according to the FDA’s report. Agency staff said this suggests a trend toward higher stroke rates with the pump compared to other devices. If the device is approved, HeartWare most likely will have to conduct a post-approval study on the safety and effectiveness of the device by body surface area and quality of life five years after the date of implant. An agency representative told the panel the FDA was interested in “rigorous” post-approval data.
HeartWare’s Ventricular Assist System is designed as a bridge to heart transplantation in patients with end-stage heart failure. Photo courtesy of HeartWare International Inc. |
Of the nearly 140 patients who used HeartWare’s device in the final-phase trial (called ADVANCE), 90.7 percent survived, according to the company. This is compared with 90.1 percent of 499 patients in a registry for patients who use mechanical circulatory support for advanced heart failure, such as the HeartMate II, made by Pleasanton, Calif.-based Thoratec Corp. This is the first LVAD trial to use a registry as a control arm—which broke new ground as far as what the FDA accepts for trial data. The primary endpoint of the trial was being alive after 180 days, or receiving a transplant. Panelists struggled with determining what sort of safety comparisons could be made between the HeartWare and registry arms of the trial— particularly when comparing stroke rates between HeartWare patients and the control group. The HeartMate II VAS is surgically implanted in an abdominal pouch, and the HeartWare VAS is implanted next to the heart.
Eleven patients who received the HeartWare device had an ischemic stroke within 180 days (27 percent of whom died or else were no longer eligible for a heart transplant) and four patients died of a hemorrhagic stroke. But whether 11 ischemic strokes is a high or low number is unclear, because stroke data wasn’t tracked in the registry. One panelist suggested 11 strokes is not a lot, especially given the alternative of not getting an LVAD, which for most patients would mean death. There were six deaths in the HeartWare group, three of which appeared to be related directly to the device. Still, the death rate was lower in the HeartWare group than in the registry group (4.3 percent compared to 8.8 percent).
Despite gaps in safety data, panelists seem to feel that another bridge-to-transplant LVAD option should be available for critically ill patients.
“I think this device is of incredible benefit to patients who are very ill,” said panelist Ralph Brindis, M.D., a cardiologist at Oakland Kaiser Medical Center in Oakland, Calif.
The U.S. market for left ventricular pumps may pass $750 million in 2015, Jason Mills, an analyst with Canaccord Adams Inc. in San Francisco, Calif., told Bloomberg news. Mills said if HeartWare’s product is approved for heart-failure patients who aren’t eligible for a transplant, the company may split the U.S. market with HeartMate II within the next three years. Thoratec currently dominates the worldwide ventricular assist device market with about 68 percent of the market share, according to data compiled by Bloomberg analyst Michael Manns. HeartMate had $366 million in revenue last year.
HeartWare currently is recruiting patients for a study on the device’s use in patients who aren’t eligible for a heart transplant, according to the National Institutes of Health website, clinicaltrials.gov.
Acting panel chair, Richard Page, M.D., a professor at the University of Wisconsin School of Medicine and Public Health, called the HeartWare device “a real advance in technology” but said the ADVANCE trial was poorly conducted—“a mess,” he called it.
“We are pleased with the panel’s strong recommendation and would like to thank them for their thoughtful review of the data presented from the ADVANCE study,” said Doug Godshall, CEO and president of Framingham, Mass.-based HeartWare. “The Advisory Committee meeting outcome represents an important step toward approval of the HeartWare Ventricular Assist System in the United States, and we look forward to continuing our dialogue with the FDA as it finalizes its review of our PMA (premarket approval application). HeartWare remains committed to optimizing outcomes for patients with end-stage heart failure and looks forward to expanding the clinical experience for the device in the future.”
HeartWare originally submitted its PMA to the FDA in 2010.
Danielle Antalffy, an analyst with Boston, Mass.-based Leerink Swann, predicted in a note that FDA approval could be delayed until late fourth quarter of 2012 while the agency collects more information on the sintered HVAD—the small implantable centrifugal blood pump located at the center of the HeartWare device. Sintering titanium is a process by which minute beads are metallurgically affixed to a titanium surface; the practice commonly is used in medical devices to facilitate tissue adhesion at the sintered region. Sintering of the HVAD pump on the outer surface of the implanted inflow tube is designed to promote tissue in-growth on the lower section of the inflow tube. More time will allow increased data to be available from ongoing continued access protocol patient enrollment. Antalffy and colleagues previously had predicted a third-quarter approval.
The FDA is not bound by its advisory panel recommendations, but it usually follows them.
AdvaMed’s New Chairman Outlines Group’s Three-Year Advocacy Plan
The Advanced Medical Technology Association (AdvaMed), held a conference call recently with the group’s new chairman of the board David Dvorak, CEO of Zimmer Holdings Inc. Dvorak began the call by giving a rundown of his vision for the association for the next three years.
Dvorak is no stranger to the Washington, D.C.-based industry trade group. He has served AdvaMed in various capacities during the past 10 years. He has been an active member of the board since 2006 and has served as chairman of the association’s orthopedics sector since 2004. For the past two years he chaired AdvaMed’s Payment & Health Care Delivery Committee, where he led the association’s
efforts to ensure that new payment delivery programs—such as accountable care organizations and bundling systems—support medical innovation and preserve patient/physician choice.
He highlighted the importance of:
- Preserving patient access to medical technology;
- Working with the U.S. Food and Drug Administration to improve efficiency; and
- Repealing the medical device excise tax that was passed as part of the healthcare reform act.
He then articulated his intent for the association to:
- Increase its operational presence in international markets, particularly in India and China;
- Increase in-house research so that the association has access to data-driven analysis of market trends and industry behavior; and
- Listen to patients to learn what they need most.
Dvorak said it was particularly important to “move beyond the beltway (the highway that surrounds Washington, D.C.) and listen to patients to better understand what they need.”
When asked, Dvorak clarified that these goals are extensions of what already is in place within AdvaMed, rather than brand new initiatives. He also said that any new in-house research will be made as public as possible in the interest of transparency.
Dvorak expressed a sense of unity with the global medtech industry.
“All governments are facing the same problems,” he said. “Aging populations, chronic disease, economic issues. I see the medical technology industry as a solution as it promotes public health.”
User Fee Inches Closer to Reauthorization
During its mark-up session on April 25, the Senate’s Health Education and Labor Committee voted to move the U.S. Food and Drug Adminstration’s user fee reauthorization legislation to the U.S. Senate floor for a full vote. A mark up also was scheduled in the U.S. House of Representatives, but has been delayed (and was not held as of press time). The delay could be due to squabbling between Democrats and Republicans about medical device approval language.