Archive for the ‘Stents & Tools’ Category

Tommy King Memorial Cardiovascular Symposium

Saturday CEUs in Boston, May 20

St. Elizabeth’s Medical Center

Boston, MA

May 20

7:30am – 3pm


07:30am | Registration & Continental Breakfast

08:00am | Hemodynamics; Faisal Khan, MD, St. Elizabeth’s Medical Center

09:00am | Radiation Protection; Satish Nair, PhD, F.X. Masse Associates

10:00am | Break & Exhibits

10:15am | Structural Heart – TAVR Updates and Watchman

Joseph Carrozza, MD, St. Elizabeth’s Medical Center

11:15am | Road to the Cath Lab — Triggers for STEMI Activation 

Lawrence Garcia, MD, St. Elizabeth’s Medical Center

12:15pm | Lunch

01:00pm | HF Program including Cardiomems

Lana Tsao, MD & Jaclyn Mayer, NP, St. Elizabeth’s Medical Center

02:00pm | Cath Lab Pharmacology

Mirembe Reed, Pharm.D, St. Elizabeth’s Medical Center

Register now »


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ACC 2017, 3/30/2017 – Poor Outcomes for Bioresorbable Stents in Small Coronary Arteries



Bioresorbable Stent Comparable to Xience at Two Years, With Concerns


Stephen Ellis, M.D., professor of medicine and director of interventional cardiology at Cleveland Clinic, discusses the two year outcomes of the ABSORB III trial of Absorb vs. Xience. The late-breaking trial was presented at ACC 2017. Read the article on the ABSORB III results.  Watch a VIDEO with Gregg Stone, M.D., “Poor Outcomes for Bioresorbable Stents in Small Coronary Arteries.”



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FDA approved Absorb GT1 Bioresorbable Vascular Scaffold System (BVS), Everolimus releasing and Absorbed by the body in 3 years

Reporter: Aviva Lev-Ari, PhD, RN

FDA approves first absorbable stent for coronary artery disease

For Immediate Release

July 5, 2016


The U.S. Food and Drug Administration today approved the first fully absorbable stent to treat coronary artery disease. The Absorb GT1 Bioresorbable Vascular Scaffold System (BVS), which releases the drug everolimus to limit the growth of scar tissue, is gradually absorbed by the body in approximately three years.

“The FDA’s approval of the Absorb GT1 BVS offers a new treatment option for individuals who are candidates for angioplasty, but would prefer an absorbable device rather than a permanent metallic coronary stent,” said Bram Zuckerman, M.D., director of the division of cardiovascular devices at the FDA’s Center for Devices and Radiological Health.

Coronary heart disease is responsible for about 370,000 deaths each year in the U.S., according to the National Heart, Lung, and Blood Institute. The condition develops when cholesterol-containing deposits build up and narrow the coronary arteries, decreasing blood flow to the heart. This can cause chest pain (angina), shortness of breath, fatigue or other heart disease symptoms. Doctors often treat coronary artery disease with a procedure called angioplasty to widen the artery using a metal stent. Scar tissue can form within the stent causing the artery to narrow again (restenosis). Drug-eluting stents temporarily release a drug, typically for a few months after stent placement, to combat the formation of scar tissue.

The Absorb GT1 BVS is manufactured from a biodegradable polymer called poly(L-lactide), which is similar to materials used in other types of absorbable medical devices, such as sutures. The device’s absorption by the body gradually eliminates the presence of foreign material in the artery once the stent is no longer needed. After absorption, there are only four very small platinum markers embedded in the walls of the artery, which help cardiologists identify where the Absorb GT1 BVS was originally placed.

In approving the Absorb GT1 BVS, the FDA evaluated data from a randomized trial of 2,008 patients, which compared the rate of major adverse cardiac events between the Absorb GT1 BVS and a drug-eluting metallic stent. After one year, the Absorb GT1 BVS group showed a major cardiac adverse event rate of 7.8 percent, which was clinically comparable to the rate of 6.1 percent observed in the control group. In addition, after one year, the rate of blood clots forming within the devices was 1.54 percent for the Absorb GT1 BVS and 0.74 percent rate for the control.

Possible adverse events that may be associated with the procedure to insert the Absorb GT1 BVS or with the Absorb GT1 BVS itself include allergic reactions to materials in the device or medications used during the procedure, allergic reaction to the drug everolimus, infection or irritation at the catheter insertion site, internal bleeding, the development of abnormal connections between arteries and veins, embolism, or other coronary artery complications that may require medical intervention and that could lead to death.

The Absorb GT1 BVS is contraindicated for patients who have a known hypersensitivity or allergy to everolimus or the materials used in the device, such as poly(L-lactide), poly(D,L-lactide), or platinum. It is also contraindicated for those who are not candidates for angioplasty, have sensitivity to contrast, or who cannot take long-term aspirin therapy along with other blood-thinning medications (antiplatelet agents).

The Absorb GT1 BVS is manufactured by Abbott Vascular in Santa Clara, California.

The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.


Page Last Updated: 07/05/2016

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Ngai-Yin Chan-The Practice of Catheter Cryoablation for Cardiac Arrhythmias[PDF] 20 MB PDF…

Sourced through from:

See on Scoop.itCardiovascular Disease: PHARMACO-THERAPY

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Top 10 Medical Innovations for 2016 by Cleveland Clinic

Reporter: Aviva Lev-Ari, PhD, RN


What are the up-and-coming technologies and which will have the biggest impact on healthcare in 2016?

Cleveland Clinic’s culture of innovation naturally fosters a good deal of discussion about new “game changing” technologies and which ones will have the greatest impact each year. The passion of our clinicians and researchers for getting the best care for patients drives a continuous dialogue on what state-of-the art medical technologies are just over the horizon.

This content was developed to share outside Cleveland Clinic what our clinical leaders are saying to each other and what innovations they feel will help shape healthcare over the next 12 months.

#10 Neurovascular Stent Retrievers
The immediate hours after suffering an ischemic stroke are critical. The clot that occurs within a blood vessel must be removed within 3-6 hours in order to prevent long term disability, brain damage or death. For years, the only FDA-approved treatment for removing clots has been a tissue plasminogen activator, or tPA. The medicine, delivered intravenously, travels to the clot and dissolves and restores blood flow to the brain. When an occlusion forms in a major vessel, however, tPA has been effective in less than a third of all patients. Scientists for years have been looking for reinforcements that could aid tPA in eliminating main-stem clots as quickly and as safely as possible. The result is the Stent Retriever.


#9 Frictionless Remote Monitoring
The wearable technology market has been skyrocketing in recent years. A recent study has estimated that 20% of American adults are wearing a device that collects data on anything from exercise and sleep habits to heart rate and blood pressure. The wide adoption has led to excitement about a potentially healthier population in the coming years. In addition to wellness, there are millions of sick patients that can benefit directly from wearables that are monitoring data at every breath, bead of sweat, or chemical change in the body. In many cases the reaction to these alterations can mean life or death.

#8 First Treatment for HSDD
Sexual desire is different from sexual performance. There are several medications that address male sexual dysfunction. But none that address loss of sexual desire in women. Until now. In 2015, the FDA approved flibanserin, the first medication designed to treat female hypoactive sexual desire disorder (HSDD), or loss of sexual desire in premenopausal women.

#7 Naturally Controlled Artificial Limbs
There have been numerous innovations in prosthetics over the years that have been able to mimic the natural movement, and provide a large boost to the quality of life of amputees and paralyzed individuals. But with over 6 million people paralyzed and 100,000 Americans living with an upper arm amputation, there is a large patient population that is paying close attention to an innovation that will yet again revolutionize the use of prosthetics.

#6 Cancer Screening via Protein Biomarker Analysis
To understand the risk of cancer, scientists for years have focused narrowly on changes in the concentration of a single protein in biological fluids such as blood or urine or, alternatively, on genetic mutations. However, relatively poor sensitivity, specificity and predictive value generally limit the diagnostic accuracy and clinical utility of these tests.

#5 Cell-free Fetal DNA Testing
The market in pregnancy wellness has grown to almost $2 billion as new parents increasingly invest in books, diets, and yoga classes all dedicated to ensuring their baby will be as healthy as possible when arriving. The potential for genetic diseases, like Down’s Syndrome, Edwards Syndrome, and Patau Syndrome however, are out of the control of the mother, and can therefore cause a great deal of stress, especially due to the vague and uncertain results of present tests.

#4 Water Purification Systems for Prevention of Infectious Diseases
In the developing world, it is not uncommon to see sewage pile up in the streets with nowhere to go but into the local drinking water. This is an issue that contributes to more than 10% of the disease burden on the entire world. It is estimated that more than 700 million people in the world are drinking unsafe water every day, and according to the World Health Organization, more than a million children under the age of five in developing nations die each year as a result of contaminated water and poor sanitation.

#3 Gene Editing using CRISPR
Not long ago, the ability to alter DNA of any organisms, including human embryos, was an idea thought up by science fiction authors and movie directors. A new technique, called CRISPR, however is proving not only that it’s possible, but that it can be done very easily and at very little cost when compared to prior gene editing attempts. And as a result — it is being adopted in labs everywhere.

#2 Genomics-based Clinical Trials
Genomics-based clinical trials are speeding the development of new targeted therapies. They sort potential research participants by genetic criteria, and match them with the experimental therapy that targets the particular molecule associated with their disease. Genetic profiling shortens the time it takes to enroll patients and increases the chance that patients will benefit from the therapy being studied.

#1 Vaccines to Prevent Public Health Epidemics
The number one spot in the 2015 Top Ten Medical Innovation goes to the scientists, physicians and public health officials who are developing safe, efficient and effective vaccines faster than ever to prevent disease epidemics. These efforts were given new urgency by the 2014 Ebola epidemic in Africa and of bacterial meningococcal (Meningococcal B) outbreaks in the United States. In both cases, physicians, scientists, companies and government agencies innovated with unprecedented speed to move new vaccines from laboratories to clinical testing in large populations.



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Abbott’s Bioabsorbable Stent met its Primary Endpoint in a U.S. Clinical Trial, applications for FDA Approval follows

Reporter: Aviva Lev-Ari, PhD, RN


Absorb device is designed to fully dissolve after delivering its anti-restenosis drug payload, unlike conventional drug-eluting stents what leave behind a metal scaffold.


TCT 2015: Abbott’s Absorb meets endpoint in U.S. pivotal trial

One-year data from the Absorb III trial of 2,008 patients showed that the Absorb device was non-inferior to Abbott’s flagship Xience drug-eluting stent. The Absorb device is designed to fully dissolve after delivering its anti-restenosis drug payload, unlike conventional drug-eluting stents what leave behind a metal scaffold.

The trial showed a rate of target lesion failure of 7.8% for the Absorb arm and 6.1% for the Xience arm and no significant difference in rates of cardiac death (0.6% for the Absorb stent and 0.1% for the Xience stent); target vessel myocardial infarction (6.0% and 4.6%, respectively); or ischemia-driven target-lesion revascularization (3.0% and 2.5%, respectively. Device thrombosis occurred in 1.5% of Absorb patients and 0.7% of Xience patients, according to the study, which was also published in the New England Journal of Medicine.

“The Absorb III data shows that there are no statistically significant 1-year differences between Absorb and Xience, which is a major accomplishment given Xience’s strong performance as the current standard of care,” co-principal investigator Dr. Dean Kereiakes of Cincinnati’s Christ Hospital Heart & Vascular Center said in prepared remarks. “Naturally dissolving heart stents are the next revolution in percutaneous coronary intervention, and Absorb is leading the way as an innovative option. Absorb does its job and then restores the vessel to its natural state over time, which cannot be achieved with a permanent drug eluting stent.”

During a press conference discussing the results, Kereiakes cited Absorb’s performance in the context of a 1st-generation device going up against what he called the “gold standard” in Xience.

“The remarkable thing is that a gen-1 device really goes toe to toe [with Xience],” he said. “Longer-term evaluation is ongoing to determine if Absorb improves late outcomes compared with Xience.”

Asked about the value proposition for Absorb versus Xience, Dr. Daniel Simon of Cleveland’s Harrington Heart & Vascular Institute said providers are usually willing to pay a little more for new technologies.

“In medicine, in general, when you have technological iterations and innovations, one tends to pay more,” Simon said, noting that . “Health systems allow for companies to make fair profit, [in order] to have advances in medicine. … The long and the short of it is, we’ll pay a little more for a device that patients are asking for.”

Data from 2 other studies presented today at TCT 2015, Absorb II and Absorb China, also showed that the Absorb device functions similarly to Xience.

“The trial met all its major endpoints, and given all the attributes my opinion is that it should be approvable,” said Dr. Gregg Stone of New York’s Columbia University Medical Center, global chairman of the study. “We’ve got good reason to be very hopeful that the long-term outcomes for patients will be improved with this device compared with a normal metallic drug-eluting stent.

“A lot of patients would much rather have a dissolving stent that returns arteries back to their normal condition,” Stone said. “It will be very good for young patients who will live 30 or 40 years with this decision.”

“Results of the Absorb III pivotal trial show that Absorb is comparable to the best-in-class metallic stent. However, because Absorb leaves nothing behind it may provide significant longterm benefits, such as a restored vessel in a natural state and renewed possibilities for people treated with Absorb,” added Abbott vice president Dr. Charles Simonton in a press release. “At Abbott we will continue to study Absorb in our robust clinical trials to show the long-term benefits of Absorb that differentiate it from permanent, metallic stents.”

Material from Reuters was used in this report.



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