Doctors typically use angioplasty, which widens an artery through the use of a metal stent, to treat the disease. However, the stents often cause scar tissue to form, which results in the artery narrowing again.
VANISHING. Abbott Vascular’s Absorb GT1 Bioresorbable Vascular Scaffold (BVS) System is the first fully absorbable stent.
Drug-eluting stents release a medication for a few months after they’re inserted into an artery to combat the formation of scar tissue. In July 2016, FDA approved Abbott Vascular’s Absorb GT1 Bioresorbable Vascular Scaffold (BVS) System, which is the first fully absorbable drug-eluting stent. The stent, which is made of a biodegradable polymer that’s similar to the material that’s used to dissolve sutures, widens the artery and releases the medication everolimus for 6–12 months to limit scar tissue. The stent is absorbed by the body in 3 years. All that remains are four tiny platinum markers that are embedded in the walls of the artery to help cardiologists to identify where the device was placed.
Dr. James C. Blankenship, who is the past president of Society for Cardiovascular Angiography and Interventions, which is a professional association, calls the Absorb GT1 BVS System a “paradigm shift.” (Researchers tried to develop an absorbable stent for the past 20 years, he says.) However, he says, 10–20 years of data will be required to determine whether the Absorb GT1 BVS System yields any clinical benefits, such as whether it helps patients to live longer or whether it prevents heart attacks.
In addition, he says, “there may be a psychological benefit in that people feel better [when] they don’t have a piece of metal in their body.”
Blankenship tells us that the Absorb GT1 BVS System is thicker and more difficult to insert into the artery than are conventional metal stents. Future bioresorbable stents will be thinner, he says. Filmore tells us that other absorbable stents that are in development are made of polymers that dissolve faster than does the Absorb GT1 BVS System.
Abbott launched the Absorb GT1 BVS System in late 2016 in the United States, and the company is training doctors on how to implant it in patients. (You can find a map of hospitals where it’s available at dissolvingstent.com.) Blankenship says the GT1 BVS System costs no more than does a conventional stent, which typically costs $1,200, according to ECRI Institute, which is a medical-research organization. The Absorb GT1 BVS System typically is covered by insurance, he says.
MAKING WAY. V-Wave Medical’s V-Wave Shunt treats heart failure with preserved ejection fraction.
REDUCING PRESSURE. New minimally invasive interatrial shunts show a potential to treat heart failure with preserved ejection fraction (HFpEF), which is a difficult-to-treat condition that causes pulmonary congestion. About half of the estimated 500,000 new heart-failure cases that are diagnosed annually in the United States are classified as HFpEF.
ECRI Institute says two interatrial shunts are in development: Corvia Medical’s InterAtrial Shunt Device and V-Wave Medical’s V-Wave Shunt. Neither device is approved for sale in the United States, but ECRI Institute expects an early adoption of interatrial shunts to take place in a few years.
Interatrial shunts are implanted in patients to create a permanent opening in the wall that separates left and right atrial chambers of the heart. The shunts help to relieve elevated left-atrial pressure by allowing blood to flow from the higher pressure left atrium into the lower pressure right atrium. The idea is to equalize pressure and relieve pulmonary congestion, ECRI Institute says.
The shunts are considered to be a breakthrough, because no other therapy “has proven to work to improve clinical outcomes for this population,” says Dr. Christopher O’Connor, who is the editor-in-chief of Journal of American College of Cardiology: Heart Failure. “The landscape is not crowded for new therapies in this place.”
Early studies that were published in March 2016 in The Lancet, which is a British medical journal, showed that after the InterAtrial Shunt Device and V-Wave Shunt Device were implanted, patients had fewer heart-failure symptoms and were able to exercise for longer periods.
No one could tell us how much that interatrial shunts will cost. ECRI Institute says they’ll cost somewhere between the price of a cardiac stent, which starts at $2,500, and a prosthetic cardiac implant valve, which starts at $20,000.
MANAGING MS. Experts say they expect that in late March 2017, FDA will approve Genentech’s Ocrevus (ocrelizumab), which is the first medication that shows results in the treatment of relapsing-remitting multiple sclerosis (RRMS) and primary progressive multiple sclerosis (PPMS).
RRMS is the most common form of MS, according to National Multiple Sclerosis Society (NMSS). Patients typically experience the initial symptoms, such as episodes of double vision, numbness and decreased neurological function, in their 20s and 30s. For those who have RRMS, the symptoms will disappear and relapse until the disease progresses 10–20 years later into secondary progressive multiple sclerosis (SPMS), which is characterized by symptoms that worsen.