The Cleveland Clinic unveiled its picks for the Top 10 Medical Innovations list for 2020.
The Top 10 Medical Innovations list is published each year. It is determined through expert opinions of Cleveland Clinic physicians and researchers. Close to 100 experts are interviewed and more than 150 nominations are considered. Two committees review, discuss, judge, and rank the nominations. Combined lists are then evaluated to establish the final top 10 list.
All nominations must meet the following eligibility criteria, according to Cleveland Clinic:
- The innovation must have significant clinical impact and offer significant patient benefit in comparison to current practices. It must also have high user-related functionality that improves healthcare delivery such as providing custom medical vehicles.
- Nominated innovations must have a high probability of commercial success.
- The innovation must be in or exiting clinical trials and be available on the market sometime in the coming year.
- The innovation must have significant human interest in its application or benefits and must have the ability to visualize human impact.
Here is Cleveland Clinic’s Top 10 Medical Innovations list for 2020.
Romosozumab is a dual-acting osteoporosis drug that received Food and Drug Administration (FDA) approval in April. According to Cleveland Clinic, “Treatment for osteoporosis includes medications, healthy diet, and weight-bearing exercise to help prevent bone loss or strengthen already weak bones. Since 1995, drug therapy for the condition was limited to antiresorptive agents – medications to slow down bone loss. In 2002, anabolic medications became popular – acting to increase bone formation by stimulating the cells that build bone. The stimulation seen with these anabolic medications, however, increased bone resorption as well – mitigating some of their reinforcement effect. But a new drug is remedying this catch 22.”
The FDA’s approval of romosozumab-aqqg, marketed as Evenity, also came with a boxed warning for possible increased risk of heart attack, stroke, and cardiovascular death.
Romosozumab-aqqg was tested in two clinical trials that included a total of more than 11,000 women with postmenopausal osteoporosis. The first trial compared one-year efficacy of romosozumab-aqqg to placebo and found that it reduced the risk of new vertebral fracture by 73% compared to placebo; this continued over the second year as well when the medication was followed by a year of denosumab—another osteoporosis therapy—compared to placebo followed by denosumab. The second trial compared romosozumab-aqqg to alendronate—another osteoporosis therapy—and found that one year of romosozumab-aqqg reduced new vertebral fracture risk by 50% compared to two years of alendronate. It was in this trial—not the placebo trial—where an increased risk was observed for cardiovascular death, heart attack, and stroke. Romosozumab-aqqg is therefore not indicated for patients who have had a heart attack or stroke within the previous year.
Earlier this year the European Medicine Agency’s Committee for Medicinal Products for Human Use announced it has adopted a negative opinion of Evenity.
#2 New Indication for Minimally Invasive Mitral Valve Surgery
In 2013, minimally invasive surgery for mitral valve repair provided patients a less invasive alternative for mitral regurgitation. However, this option was only approved in patients with primary or degenerative mitral regurgitation who were not approved for open-heart surgery.
This changed in March, when the FDA expanded its approval to include patients with secondary or functional mitral regurgitation.
“Expanding the approval of the device to this population of patients who have failed to get symptom relief from other therapies provides an important new treatment option,” Cleveland Clinic noted. “This expanded use of the minimally invasive method is removing some risk, fear, and inconvenience from the cardiac surgery equation.”
#3 First ATTR-CM Medication
Transthyretin amyloid cardiomyopathy (ATTR-CM) often goes mis- or undiagnosed because its symptoms mirror those of other diseases. If left untreated, it could be fatal. There are two known types of ATTR-CM. One is genetic and attributable to a mutated transthyretin gene. The other type is referred to as wild-type ATTR-CM, or acquired ATTR-CM, and is not passed down genetically. Both types could be deadly.
Cleveland Clinic wrote of the new innovation, “Previously, no medication existed for the treatment of either type of ATTR-CM. Treatment for the condition was limited to an unlikely heart transplant. But in May 2019, an approval provided hope for the suffering population. Approval of two drug formulations of the compound known as tafamidis dubbed the first ever treatment for both hereditary and wild-type ATTR-CM. The two drugs are approved for ATTR-CM in adults to reduce cardiovascular mortality and cardiovascular-related hospitalization.”
#4 Peanut Allergy Therapy
An expert FDA panel recommended the use of a novel immunotherapy for patients with peanut allergies. The oral biologic drug provides a 300 mg daily dose of peanut protein, allowing patients to build enough of a tolerance to peanuts where an accidental exposure would not cause alarm. In a recent trial, about 80% of patients achieved the daily maintenance dose, equivalent to one peanut; about 66% were able to tolerate two peanuts per day after nine to 12 months of treatment, and close to half of patients reached the four-peanut level.
#5 Closed-loop SCS
Spinal cord stimulation (SCS) for the treatment of chronic pain caused by nerve damage in the trunk, arms, or legs first received FDA approval in 1989. The closed-loop design could eliminate the risk of overstimulation that causes decreased pain relief. This new technology communicates in real time with the neurons of the spinal cord.
“The device is the first to measure the cord’s response to stimulation via evoked compound action potentials (ECAPs), and adjust on every pulse to maintain activation with the patient’s therapeutic window. No matter what the patient’s activity (sitting, standing, etc.) the new system ensures a level of stimulation for optimal pain relief,” Cleveland Clinic described.
The following innovations rounded out the top 10 list:
#6 Biologics in Orthopedic Repair
#7 Antibiotic Envelope for Cardiac Implantable Device Infection Prevention
#8 Bempedoic Acid for Cholesterol-Lowering in Statin Intolerant Patients
#9 PARP Inhibitors for Maintenance Therapy in Ovarian Cancer
#10 Drugs for Heart Failure with Preserved Ejection Fraction