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Archive for the ‘Stents & Tools’ Category

Bioresorbable Stent Clinical Trials with New Esprit Below-the-knee Scaffold

Posted in Cardiac and Cardiovascular Surgical Procedures, Medical Devices R&D and Inventions, Peripheral Arterial Disease & Peripheral Vascular Surgery, Stents & Tools, tagged , , , , on October 9, 2020| Leave a Comment »

Bioresorbable Stent Clinical Trials with New Esprit Below-the-knee Scaffold

Reporter: Irina Robu, PhD

Abbott announced on September 3, 2020, the beginning of the LIFE-BTK clinical trial to evaluate effectiveness and safety of  the Esprit BTK Everolimus Eluting Resorbable Scaffold System. The Esprit BTK System consists of a thin strutted scaffold made of poly-L-lactide, a semi-crystalline bioresorbable polymer engineered to resist vessel recoil and provide a platform for drug delivery. The scaffold is coated with poly-D, L-lactide (PDLLA) and the cytostatic drug, everolimus.

This trial is the first Investigational Device Exemption in the US to assess a fully bioresorbable stent to treat blocked arteries below the knees, also known as critical limb ischemia in people battling advanced stages of peripheral artery disease. For people with CLI, blocked vessels weaken blood flow to the lower extremities, which can lead to severe pain, wounds, and in severe cases, limb amputation.

At this time, the standard of care for patients battling critical limb ischemia is balloon angioplasty, which depend on on a small balloon delivered via a catheter to the blockage to compress it against the arterial wall, opening the vessel and restoring blood flow. Yet, blockages treated only with balloon angioplasty have poor short- and long-term results, and in many cases the vessels become blocked again, lacking additional treatment.

Patients treated with balloon angioplasty often require several procedures on treated arteries, and  a drug eluting resorbable device is if at all possible suited to provide mechanical support, decrease the chance of the vessel re-narrowing and then slowly disappear over time. At this time, there are no drug eluding stents, drug coated balloons or bare metal stents approved for use below the knee. Since, there is a limited number of options for stents below the knee, the FDA has granted Esprit BTK breakthrough device designation, which simplifies review and pre-market approval timelines.

According to Abbott, Espirit BTK System is not a permanent implant, but it does provide support to an artery right after a balloon angioplasty, stopping the vessel from reclosing. As soon as it is implanted, the scaffold distributes a drug over a few months that encourages healing and keeps the artery open. The scaffold is naturally resorbed into the body over time, like dissolving sutures, and eventually leaves only a healed artery behind.

The LIFE-BTK trial is the first Investigational Device Exemption trial in the U.S. to evaluate a fully dissoluble device to treat critical limb ischemia in people battling advanced stages of peripheral artery disease (PAD). The trial will be run by principal investigators Brian DeRubertis, M.D. (vascular surgeon, UCLA), Sahil Parikh M.D., (interventional cardiologist, New York-Presbyterian/Columbia University Irving Medical Center.

SOURCE

https://www.dicardiology.com/article/abbott-restarts-bioresorbable-stent-clinical-trials-new-esprit-below-knee-scaffold

 

 

 

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Targeting Atherosclerotic Plaques with Stents made of Drug-eluting Biomaterials

Posted in Biodegradable Drug-eluting Material, Bioresorbable Vascular Scaffold (BVS), Cardiac and Cardiovascular Surgical Procedures, Frontiers in Cardiology and Cardiovascular Disorders, PCI, Peripheral Arterial Disease & Peripheral Vascular Surgery, Stents & Tools, Vascular Diseases on June 9, 2020| Leave a Comment »

Targeting Atherosclerotic Plaques with Stents made of Drug-eluting Biomaterials

Reporter: Daniel Menzin, BSc BioMedical Engineering, expected, May 2021, Research Assistant 4, Core Applications Developer and Acting CTO 

 

Atherosclerosis is a chronic cardiovascular disease with a multitude of different implications. A coronary artery plaque may lead to congestive heart failure while an aortic plaque may cause angina. Both can quite possibly lead to a heart attack unless properly managed. One way to manage this condition is through the use of stents made of a mesh that is expanded following placement into the diseased vessel.

Unfortunately, stents are oftentimes initially effective but eventually restenosis occurs. Restenosis is a condition in which the affected vessel becomes blocked again. Cholesterol-rich blood vessel environments oftentimes lead to an irritation that results in white blood cells aggregating in the area and releasing proinflammatory chemokines and cytokines, which cause fibrosis. To make matters worse, the cholesterol plaques undergo compression against the vessel wall which causes vessel injury and further inflammation. This leads to thrombus formation and may potentiate neointimal hyperplasia, an abnormal proliferation and migration of smooth muscle cells in the tunica intima. Neointimal hyperplasia plays a major role in restenosis.

Recent research has found that interfacing drug eluting biomaterials with stents may help prevent restenosis. One study showed that rapamycin delivered with acid labile and ROS-sensitive forms of Beta-cyclodextrin produced promising results when treating atherosclerosis in rat models (Dou, et al). In this promising new paradigm of treatment, non-proinflammatory biomaterials are interfaced with stents. Once inflammation appears the biomaterial will begin to degrade, slowly releasing the drug which suppresses the underlying immune reaction and the resulting inflammation.

 

SOURCE

Dou Y;Chen Y;Zhang X;Xu X;Chen Y;Guo J;Zhang D;Wang R;Li X;Zhang J; “Non-Proinflammatory and Responsive Nanoplatforms for Targeted Treatment of Atherosclerosis.” Biomaterials, U.S. National Library of Medicine, 29 July 2017, pubmed.ncbi.nlm.nih.gov/28778000/.

 

Other related articles published in this Open Access Online Scientific Journal include: 

75 articles found in the search 

https://pharmaceuticalintelligence.com/?s=drug+eluting+stents

 

Among them:

Stent Design and Thrombosis:  Bifurcation Intervention, Drug Eluting Stents (DES) and Biodegrable Stents

Curator: Aviva Lev-Ari, PhD, RN

https://pharmaceuticalintelligence.com/2013/08/06/stent-design-and-thrombosis-bifurcation-intervention-drug-eluting-stents-des-and-biodegrable-stents/

 

Drug Eluting Stents: On MIT‘s Edelman Lab’s Contributions to Vascular Biology and its Pioneering Research on DES

Author: Larry H Bernstein, MD, FACP and Curator: Aviva Lev-Ari, PhD, RN

https://pharmaceuticalintelligence.com/2013/04/25/contributions-to-vascular-biology/

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Palmaz, Pinchuk, Schatz, Simpson and Yock are the 10th recipients of the Russ Prize for innovations leading to the widespread adoption of PCI at NAE Gala Ceremony, 2/20/2019, WashDC

Posted in Cardiac and Cardiovascular Surgical Procedures, Frontiers in Cardiology and Cardiovascular Disorders, Interviews with Scientific Leaders, PCI, Russ Prize recognizes bioengineering achievements worldwide, Stents & Tools on January 16, 2019| Leave a Comment »

Palmaz, Pinchuk, Schatz, Simpson and Yock are the 10th recipients of the Russ Prize for innovations leading to the widespread adoption of PCI at NAE Gala Ceremony, 2/20/2019, WashDC

Reporter: Aviva Lev-Ari, PhD, RN

Article ID #262: Palmaz, Pinchuk, Schatz, Simpson and Yock are the 10th recipients of the Russ Prize for innovations leading to the widespread adoption of PCI at NAE Gala Ceremony, 2/20/2019, WashDC. Published on 1/16/2019

WordCloud Image Produced by Adam Tubman

 

National Academy of Engineering, Ohio University Award 2019 Russ Prize

Five interventional cardiologists awarded biennial $500,000 prize for innovations leading to the widespread adoption of PCI

National Academy of Engineering, Ohio University Award 2019 Russ Prize

January 3, 2019 — Ohio University and the National Academy of Engineering announced the 2019 Fritz J. and Dolores H. Russ Prize will be given to Julio Palmaz, Leonard Pinchuk, John Simpson, Richard Schatz and Paul Yock for innovations leading to the widespread adoption of percutaneous coronary intervention (PCI), also known as angioplasty with stent or coronary angioplasty. The $500,000 biennial prize, which recognizes a bioengineering achievement that significantly improves the human condition, cites PCI for “seminal contributions to coronary angioplasty, enabling minimally invasive treatment of advanced coronary artery disease.”

“The Russ Prize recipients personify engineering creations that advance health and healthcare every day,” said NAE President C. D. Mote, Jr.  “The PCI makes a remarkable contribution to patient well-being, helping millions afflicted with advanced coronary artery disease and significant angina. “

Ohio University alumnus and esteemed engineer Fritz Russ, BSEE ’42, HON ‘75, and his wife, Dolores Russ, established the biennial prize in 1999 with a multimillion dollar gift to Ohio University. They modeled it after the Nobel Prize, with the goal of recognizing bioengineering achievements worldwide that are in widespread use.

“This innovation — truly, sets of innovations — enables the treatment of coronary artery disease without the complexities, cost and risk of open heart surgery. Most of us have a friend or relative who has benefited greatly from angioplasty treatment,” said Russ College Dean Dennis Irwin. “These contributions have truly improved the human condition. Rewarding such innovations was the Russes’ intent.”

Percutaneous coronary intervention, also referred to as percutaneous transluminal coronary angioplasty (PTCA), is a minimally invasive procedure that uses a catheter to place a small structure called a stent to open up blood vessels in the heart that have been narrowed by plaque buildup. PCI improves blood flow, thus decreasing heart-related chest pain, making patients feel better and increasing their ability to be active. Ten of millions of patients have benefited from PCI worldwide, and this procedure has replaced or significantly delayed the need for open heart coronary bypass surgery.

Julio C. Palmaz, inventor of the first U.S. Food and Drug Administration (FDA)-approved balloon-expandable vascular stent (1990), is Ashbel Smith Professor at the University of Texas Health Science Center in San Antonio and scientific adviser of Vactronix Scientific. The Palmaz stent is on display at the Smithsonian’s National Museum of American History in Washington, D.C. In 1994 he and Richard Schatz created a modified coronary stent — two Palmaz stents joined by a single connector — approved by the FDA as the first stent indicated for the treatment of failure of coronary balloon angioplasty. The Palmaz-Schatz stent became the gold standard for every subsequent stent submitted for FDA approval.

Leonard Pinchuk is an inventor and entrepreneur in biomedical engineering, with 128 U.S. patents and 90 publications. He has co-founded 10 companies where his major accomplishments include invention of the Nylon 12 angioplasty balloon, helical wire stent, modular stent-graft, a drug-eluting stent (Taxus), several biomaterials (Bionate and polystyrene-block-isobutylene-block-styrene [SIBS]), a novel glaucoma tube (InnFocus MicroShunt), and the next-generation intraocular lens. He is a Distinguished Research Professor of Biomedical Engineering at the University of Miami.

John Simpson has helped revolutionize the field of cardiology through innovations that fundamentally altered how physicians treat cardiovascular disease. In 1981 he created a new catheter system for coronary angioplasty with an independently steerable guidewire in the central lumen of the balloon catheter, patented as the over-the-wire balloon angioplasty catheter. He now focuses his efforts on the treatment of vascular disease through the development of new technologies combined with a new approach to optical imaging.

Read the related article “Requirements for Interventional Echocardiographers”

Richard Schatz is research director of cardiovascular interventions at the Scripps Heart, Lung and Vascular Center, and director of gene and stem cell therapy. He is a recognized international expert in interventional cardiology and has published and lectured extensively. His seminal work in coronary stents spurred a revolution in the treatment of coronary artery disease — over 2 million of them are placed annually worldwide, with an immeasurable impact on relieving mortality and morbidity, improving patients’ lives, and reducing healthcare costs.

Paul Yock is the Martha Meier Weiland Professor of Medicine and founding co-chair of Stanford’s Department of Bioengineering, with courtesy appointments in the Graduate School of Business and the Department of Mechanical Engineering. He is also founder and director of the Stanford Byers Center for Biodesign. He has authored over 300 peer-reviewed publications, chapters, and editorials and two textbooks, and holds over 50 U.S. patents. Yock is internationally known for his work in inventing, developing and testing new devices, including the Rapid Exchange stenting and balloon angioplasty system, which is now the primary system in use worldwide. He also invented the fundamental approach to intravascular ultrasound imaging and founded Cardiovascular Imaging Systems (CVIS), later acquired by Boston Scientific.

“Ohio University is honored to join the National Academy of Engineering in recognizing these accomplished individuals, who have contributed to a bioengineering advancement that has enabled better health for heart patients across the world,” said Ohio University President M. Duane Nellis. “Their multi-disciplinary collaboration that lead to the development of PCI, a technology that has revolutionized coronary health, truly embraces the vision that Fritz and Dolores Russ had when creating the Russ Prize.”

Palmaz, Pinchuk, Schatz, Simpson and Yock are the 10th recipients of the Russ Prize. They will receive the award at a National Academy of Engineering gala ceremony in Washington, D.C., on Feb. 20, 2019

For more information: www.nae.edu

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Two Classes of Antithrombotic Drugs: Anticoagulants and Antiplatelet drugs

Posted in Acute coronary syndrome, Acute Myocardial Infarction, Atherogenic Processes & Pathology, Cardiovascular Research, Coagulation Therapy and Internal Bleeding, congestive heart failure, endovascular thrombectomy, Frontiers in Cardiology and Cardiovascular Disorders, Hematology, Origins of Cardiovascular Disease, Pharmacotherapy of Cardiovascular Disease, Stents & Tools, Stroke, Valves & Tools, Vascular Diseases on June 25, 2018| Leave a Comment »

UPDATED on 2/25/2019

https://www.medpagetoday.com/cardiology/prevention/78202?xid=nl_mpt_SRCardiology_2019-02 25&eun=g99985d0r&utm_source=Sailthru&utm_medium=email&utm_campaign=CardioUpdate_022519&utm_term=NL_Spec_Cardiology_Update_Active

 

ICER announced plans to look at icosapent ethyl (Vascepa) and rivaroxaban (Xarelto) as add-on therapies in cardiovascular disease.

Heart attack risk is rising among young women. But NHANES data show women are still ahead of men on control of hypertension, diabetes, and cholesterol. (Circulation)

Two Classes of Antithrombotic Drugs: Anticoagulants and Antiplatelet drugs

Reporter: Aviva Lev-Ari, PhD, RN
These drugs are used to treat
  • strokes,
  • myocardial infarctions,
  • pulmonary embolisms,
  • disseminated intravascular coagulation (DIC) and
  • deep vein thrombosis (DVT)
— all potentially life-threatening conditions.
THERAPEUTIC STRATEGIES
• Degrade fibrinogen/fibrin (fibrinolytic agents)
GOAL: eliminate formed clots
• Inhibit clotting mechanism (anticoagulants)
GOAL: prevent progression of thrombosis
• Interfere either with platelet adhesion and/or aggregation (antiplatelet drugs)
GOAL: prevent initial clot formation
Antithrombotic therapy has had an enormous impact in several significant ways.
  • Heparin has made bypass surgery and dialysis possible by blocking clotting in external tubing.
  • Antithrombotic therapy has reduced the risk of blood clots in leg veins (also known as deep-vein thrombosis or DVT), a condition that can lead to death from pulmonary embolism (a clot that blocks an artery to the lungs) by more than 70 percent. And most importantly,
  • it has markedly reduced death from heart attacks, the risk of stroke in people with heart irregularities (atrial fibrillation), and the risk of major stroke in patients with mini-strokes.

Antithrombotic Therapy

This article was published in December 2008 as part of the special ASH anniversary brochure, 50 Years in Hematology: Research That Revolutionized Patient Care.

Normally, blood flows through our arteries and veins smoothly and efficiently, but if a clot, or thrombus, blocks the smooth flow of blood, the result – called thrombosis – can be serious and even cause death. Diseases arising from clots in blood vessels include heart attack and stroke, among others. These disorders collectively are the most common cause of death and disability in the developed world. We now have an array of drugs that can be used to prevent and treat thrombosis – and there are more on the way – but this was not always the case.

Classes of Antithrombotic Drugs

Image Source: http://www.hematology.org/About/History/50-Years/1523.aspx

The most important components of a thrombus are fibrin and platelets. Fibrin is a protein that forms a mesh that traps red blood cells, while platelets, a type of blood cell, form clumps that add to the mass of the thrombus. Both fibrin and platelets stabilize the thrombus and prevent it from falling apart. Fibrin is the more important component of clots that form in veins, and platelets are the more important component of clots that form in arteries where they can cause heart attacks and strokes by blocking the flow of blood in the heart and brain, respectively, although fibrin plays an important role in arterial thrombosis as well.

There are two classes of antithrombotic drugs: anticoagulants and antiplatelet drugs. Anticoagulants slow down clotting, thereby reducing fibrin formation and preventing clots from forming and growing. Antiplatelet agents prevent platelets from clumping and also prevent clots from forming and growing.

Anticoagulant Drugs

The anticoagulants heparin and dicumarol were discovered by chance, long before we understood how they worked. Heparin was first discovered in 1916 by a medical student at The Johns Hopkins University who was investigating a clotting product from extracts of dog liver and heart. In 1939, dicumarol (the precursor to warfarin) was extracted by a biochemist at the University of Wisconsin from moldy clover brought to him by a farmer whose prize bull had bled to death after eating the clover.

Both of these anticoagulants have been used effectively to prevent clots since 1940. These drugs produce a highly variable anticoagulant effect in patients, requiring their effect to be measured by special blood tests and their dose adjusted according to the results. Heparin acts immediately and is given intravenously (through the veins). Warfarin is swallowed in tablet form, but its anticoagulant effect is delayed for days. Therefore, until recently, patients requiring anticoagulants who were admitted to a hospital were started on a heparin infusion and were then discharged from the hospital after five to seven days on warfarin.

In the 1970s, three different groups of researchers in Stockholm, London, and Hamilton, Ontario, began work on low-molecular-weight heparin (LMWH). LMWH is produced by chemically splitting heparin into one-third of its original size. It has fewer side effects than heparin and produces a more predictable anticoagulant response. By the mid 1980s, LMWH preparations were being tested in clinical trials, and they have now replaced heparin for most indications. Because LMWH is injected subcutaneously (under the skin) in a fixed dose without the need for anticoagulant monitoring, patients can now be treated at home instead of at the hospital.

With the biotechnology revolution has come genetically engineered “designer” anticoagulant molecules that target specific clotting enzymes. Anti-clotting substances and their DNA were also extracted from an array of exotic creatures (ticks, leeches, snakes, and vampire bats) and converted into drugs by chemical synthesis or genetic engineering. Structural chemists next began to fabricate small molecules designed to fit into the active component of clotting enzymes, like a key into a lock.

The first successful synthetic anticoagulants were fondaparinux and bivalirudin. Bivalirudin, a synthetic molecule based on the structure of hirudin (the anti-clotting substance found in leeches), is an effective treatment for patients with heart attacks. Fondaparinux is a small molecule whose structure is based on the active component of the much larger LMWH and heparin molecules. It has advantages over LMWH and heparin and has recently been approved by the FDA. Newer designer drugs that target single clotting factors and that can be taken by mouth are undergoing clinical testing. If successful, we will have safer and more convenient replacements for warfarin, the only oral anticoagulant available for more than 60 years.

Antiplatelet Drugs

Blood platelets are inactive until damage to blood vessels or blood coagulation causes them to explode into sticky irregular cells that clump together and form a thrombus. The first antiplatelet drug was aspirin, which has been used to relieve pain for more than 100 years. In the mid-1960s, scientists showed that aspirin prevented platelets from clumping, and subsequent clinical trials showed that it reduces the risk of stroke and heart attack. In 1980, researchers showed that aspirin in very low doses (much lower than that required to relieve a headache) blocked the production of a chemical in platelets that is required for platelet clumping. During that time, better understanding of the process of platelet clumping allowed the development of designer antiplatelet drugs directed at specific targets. We now have more potent drugs, such as clopidogrel, dipyridamole, and abciximab. These drugs are used with aspirin and effectively prevent heart attack and stroke; they also prolong the lives of patients who have already had a heart attack.

SOURCE 
Anticoagulation Drugs:
  • heparin (FONDAPARINUX HEPARIN (Calciparine, Hepathrom, Lipo-Hepin, Liquaemin, Panheprin)
  • warfarin – 4-HYDROXYCOUMARIN (Coumadin) WARFARIN (Athrombin-K, Panwarfin)
  • rivaroxaban (Xarelto)
  • dabigatran (Pradaxa)
  • apixaban (Eliquis)
  • edoxaban (Savaysa)
  • enoxaparin (Lovenox)
  • fondaparinux (Arixtra)
  • ARGATROBAN BIVALIRUDIN (Angiomax)
  • DALTEPARIN (Fragmin)
  • DROTRECOGIN ALFA (ACTIVATED PROTEIN C) (Xigris)
  • HIRUDIN (Desirudin)
  • LEPIRUDIN (Refludan)
  • XIMELAGATRAN (Exanta)

ANTIDOTES

  • PHYTONADIONE (Vitamin K1)
  • PROTAMINE SULFATE AMINOCAPROIC ACID (EACA) (generic, Amicar) (in bleeding disorders)
Antiplatelet Drugs
  • ACETYL SALICYLIC ACID (aspirin) 
  • clopidogrel (Plavix)
  • dipyridamole (Persantine)
  • abciximab (Centocor)
  • EPTIFIBATIDE (Integrilin)
  • TICLOPIDINE (Ticlid)
  • TIROFIBAN (Aggrastat)

THROMBOLYTICS

  1. ANISTREPLASE (APSAC; Eminase)
  2. STREPTOKINASE (Streptase, Kabikinase)
  3. TISSUE PLASMINOGEN ACTIVATORS (tPAs):
  • ALTEPLASE (Activase),
  • RETEPLASE (Retavase),
  • TENECTEPLASE (TNKase)
  • UROKINASE (Abbokinase)

Fibrinolytic Drugs

Fibrinolytic therapy is used in selected patients with venous thromboembolism. For example, patients with massive or submassive PE can benefit from systemic or catheter-directed fibrinolytic therapy. The latter can also be used as an adjunct to anticoagulants for treatment of patients with extensive iliofemoral-vein thrombosis.

Arterial and venous thrombi are composed of platelets and fibrin, but the proportions differ.

  • Arterial thrombi are rich in platelets because of the high shear in the injured arteries. In contrast,
  • venous thrombi, which form under low shear conditions, contain relatively few platelets and are predominantly composed of fibrin and trapped red cells.
  • Because of the predominance of platelets, arterial thrombi appear white, whereas venous thrombi are red in color, reflecting the trapped red cells.

SOURCE

https://accessmedicine.mhmedical.com/content.aspx?bookid=331&sectionid=40726858

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Tommy King Memorial Cardiovascular Symposium, St. Elizabeth’s Medical Center, Boston, May 20, 2017

Posted in Aortic Valve: TAVR, TAVI vs Open Heart Surgery, Cancer Surgery of the Heart, Cardiac and Cardiovascular Surgical Procedures, Frontiers in Cardiology and Cardiovascular Disorders, PCI, Stents & Tools, Valves & Tools, tagged on April 24, 2017| Leave a Comment »

Tommy King Memorial Cardiovascular Symposium

Reporter: Aviva Lev-Ari, PhD, RN

 

Saturday CEUs in Boston, May 20, 2017

St. Elizabeth’s Medical Center

Boston, MA

May 20

7:30am – 3pm

PROGRAM SCHEDULE & SESSIONS

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 »

SOURCE

From: <acvp@getresponse.com> on behalf of “Kurt, ACVP” <kurt@acp-online.org>

Reply-To: <kurt@acp-online.org>

Date: Monday, April 24, 2017 at 2:26 PM

To: Aviva Lev-Ari <AvivaLev-Ari@alum.berkeley.edu>

Subject: cardiovascular symposium in Boston, May 20

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

Posted in Bioresorbable Vascular Scaffold (BVS), Cardiac and Cardiovascular Surgical Procedures, Frontiers in Cardiology and Cardiovascular Disorders, Medical Devices R&D and Inventions, PCI, Stents & Tools on April 2, 2017| Leave a Comment »

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

Reporter: Aviva Lev-Ari, PhD, RN

 

WATCH VIDEO:

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.”

 

SOURCE

https://www.dicardiology.com/videos/video-bioresorbable-stent-comparable-xience-two-years-concerns

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

Posted in Cardiac and Cardiovascular Surgical Procedures, FDA Regulatory Affairs, FDA, CE Mark & Global Regulatory Affairs: process management and strategic planning - GCP, GLP, ISO 14155, Frontiers in Cardiology and Cardiovascular Disorders, PCI, Stents & Tools on July 5, 2016| Leave a Comment »

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

Release

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.

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Page Last Updated: 07/05/2016

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

Posted in Cardiac & Vascular Repair Tools Subsegment, Cardiovascular Research, Clinical Diagnostics, Electrophysiology, Frontiers in Cardiology and Cardiovascular Disorders, Heart Failure (HF), Medical Devices R&D and Inventions, Pharmacotherapy of Cardiovascular Disease, Stents & Tools, Technology Advance Assessment of, Uncategorized on February 21, 2016| Leave a Comment »

Ngai-Yin Chan-The Practice of Catheter Cryoablation for Cardiac Arrhythmias[PDF] 20 MB PDF… https://t.co/8EYkq36tJA

Sourced through Scoop.it from: www.medbooksvn.info

See on Scoop.it – Cardiovascular Disease: PHARMACO-THERAPY

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Top 10 Medical Innovations for 2016 by Cleveland Clinic

Posted in CANCER BIOLOGY & Innovations in Cancer Therapy, CRISPR/Cas9 & Gene Editing, Frontiers in Cardiology and Cardiovascular Disorders, Genetics & Pharmaceutical, Genome Biology, Immuno-Oncology & Genomics, Infectious Disease & New Antibiotic Targets, Innovation in Immunology Diagnostics, PCI, Population Health Management, Genetics & Pharmaceutical, Preimplantation Genetic Diagnosis and Reproductive Genomics, Stents & Tools on October 28, 2015| Leave a Comment »

Top 10 Medical Innovations for 2016 by Cleveland Clinic

Reporter: Aviva Lev-Ari, PhD, RN

2.2.21

2.2.21   Top 10 Medical Innovations for 2016 by Cleveland Clinic, Volume 2 (Volume Two: Latest in Genomics Methodologies for Therapeutics: Gene Editing, NGS and BioInformatics, Simulations and the Genome Ontology), Part 2: CRISPR for Gene Editing and DNA Repair

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.

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#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.

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#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.

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#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.

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#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.

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#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.

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#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.

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#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.

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#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.

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#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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SOURCE

http://www.mdtmag.com/news/2015/10/top-10-medical-innovations-2016?et_cid=4908636&et_rid=461755519&type=image

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

Posted in Cardiac and Cardiovascular Surgical Procedures, Frontiers in Cardiology and Cardiovascular Disorders, PCI, Stents & Tools on October 13, 2015| Leave a Comment »

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.

 

Update  on 10/9/2020
Bioresorbable Stent Clinical Trials with New Esprit Below-the-knee Scaffold
Reporter: Irina Robu

 

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

OCTOBER 12, 2015 BY

TCT 2015The Absorb bioabsorbable stent made by Abbott(NYSE:ABT) met its primary endpoint in a U.S. clinical trial that will be used to back a bid for FDA approval, researchers said today at the annual Transcatheter Cardiovascular Therapeutics conference in San Francisco.

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.

SOURCE

http://www.massdevice.com/tct-2015-abbotts-absorb-meets-endpoint-in-u-s-trial/?utm_source=newsletter-151013

 

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