Restenosis

Coronary Stent Co-Inventor and Gene Therapy Pioneer, Dr. Richard Schatz, Joins GATC Health as Chairman of its Medical Advisory Board

Retrieved on: 
Thursday, November 10, 2022

Dr. Schatz, a recognized international expert in interventional cardiology and co-inventor of the coronary stent, will propel GATC Health's development of novel therapeutics, diagnostics and genomic risk reports related to heart disease.

Key Points: 
  • Dr. Schatz, a recognized international expert in interventional cardiology and co-inventor of the coronary stent, will propel GATC Health's development of novel therapeutics, diagnostics and genomic risk reports related to heart disease.
  • "Dr Schatz leading our Medical Advisory Board as Chairman is a major endorsement of the value of our platform and its potential to support heart health," said Jeff Moses, President of GATC Health.
  • He was honored with both the distinguished alumnus award and the Lifetime Scholar Award by Duke University Medical Center.
  • GATC envisions the future of medicine now, where health is protected, disease is reversed and every person's unique biology is treated with precision.

6-Month Data from the Surmodics SWING BTK First-in-Human Trial Presented at AMP Europe

Retrieved on: 
Tuesday, October 11, 2022

The studys primary safety endpoint data showed no perioperative deaths or major amputations at 30 days and just one major re-intervention was reported among the 35 trial subjects.

Key Points: 
  • The studys primary safety endpoint data showed no perioperative deaths or major amputations at 30 days and just one major re-intervention was reported among the 35 trial subjects.
  • The Sundance Sirolimus Drug-Coated Balloon is not available for sale anywhere in the world, and currently is for investigational use only.
  • Surmodics is pursuing highly differentiated medical devices that are designed to address unmet clinical needs and engineered to the most demanding requirements.
  • The content of Surmodics website is not part of this press release or part of any filings that the company makes with the SEC.

6-Month Data from the Surmodics SWING First-in-Human Study to be Presented at AMP Europe

Retrieved on: 
Friday, October 7, 2022

The session will be held on Tuesday, October 11, at the Amputation Prevention Symposium (AMP) in Lugano, Switzerland.

Key Points: 
  • The session will be held on Tuesday, October 11, at the Amputation Prevention Symposium (AMP) in Lugano, Switzerland.
  • He will review safety and efficacy data collected through 6-months of follow-up for 35 patients with occlusive disease of the infra-popliteal arteries who were treated at study sites in Australia, New Zealand, or locations in Europe.
  • Study subjects will be followed for 36 months after the index procedure.
  • I am excited to present the 6-month SWING data to an audience of my peers at AMP Europe.

Efemoral Medical Awarded Phase II SBIR Grant from NIH to Advance Treatment for Peripheral Artery Disease

Retrieved on: 
Thursday, September 22, 2022

LOS ALTOS, Calif., Sept. 22, 2022 /PRNewswire/ -- Efemoral Medical, developer of advanced interventional bioresorbable therapies, announced today that it has been awarded a Phase II Small Business Innovation Research (SBIR) grant by the National Institutes of Health. SBIR grants are intended to stimulate technological innovation and encourage small United States businesses to engage in R&D with the potential for commercialization. The objective of Phase II grants is to continue the R&D efforts started under Phase I, in which the technical merit, feasibility, commercial potential of a project, and the quality of performance of the small business awardee have been established. Funds from Efemoral's award will be applied towards conducting studies aimed at characterizing the pre-clinical safety, efficacy, and foundational mechanism of action of its unique device.

Key Points: 
  • LOS ALTOS, Calif., Sept. 22, 2022 /PRNewswire/ -- Efemoral Medical , developer of advanced interventional bioresorbable therapies, announced today that it has been awarded a Phase II Small Business Innovation Research (SBIR) grant by the National Institutes of Health.
  • SBIR grants are intended to stimulate technological innovation and encourage small United States businesses to engage in R&D with the potential for commercialization.
  • "Current treatment options for patients with peripheral occlusive disease are woeful as early failures are common and the results continue to degrade over time," said Lewis B. Schwartz, MD, Co-Founder and CMO of Efemoral Medical.
  • Efemoral Medical, Inc. is developing next-generation bioresorbable solutions to treat patients with vascular disease.

Advanced NanoTherapies' SirPlux Duo Drug-Coated Balloon Receives FDA Breakthrough Designation for Small Vessel Coronary Artery Disease

Retrieved on: 
Monday, September 19, 2022

LOS GATOS, Calif., Sept. 19, 2022 /PRNewswire/ -- Advanced NanoTherapies, Inc., a privately-held medical device company committed to solving vascular disease's most significant challenges through the creative applications of nanotechnology, today announced the U.S. Food and Drug Administration (FDA) has granted the company a Breakthrough Device designation for its SirPlux Duo Drug-Coated Balloon (DCB) for coronary artery disease in vessels less than 3.0mm. This achievement comes only weeks after the company received two other critical Breakthrough Device designations for its SirPlux Duo DCB in coronary in-stent restenosis (ISR) and peripheral below-the-knee (BTK) lesions.

Key Points: 
  • This achievement comes only weeks after the company receivedtwo other critical Breakthrough Device designations for its SirPlux Duo DCB in coronary in-stent restenosis (ISR) and peripheral below-the-knee (BTK) lesions.
  • Small vessel disease (SVD), defined as atherosclerosis within small (
  • "Our third breakthrough designation emphasizes the urgent need for new coronary and peripheral therapies with a leave nothing behind approach," said Marwan Berrada-Sounni, Co-Founder and CEO of Advanced NanoTherapies.
  • The company focuses on minimally invasive cardiovascular applications to bring a safer therapeutic option to patients with coronary artery disease (CAD) or peripheral artery disease (PAD).

First and Only Peripheral Tri-axial 4-French Low-Profile Self-Expanding Stent System Receives FDA Approval

Retrieved on: 
Tuesday, July 26, 2022

LAKE OSWEGO, Ore., July 26, 2022 /PRNewswire/ -- BIOTRONIK, LAKE OSWEGO, USA, announced that it received U.S. Food and Drug Administration (FDA) approval of its innovative Pulsar®-18 T3 peripheral self-expanding stent system for an improved implantation procedure for endovascular treatments. The company also announced the full U.S. commercial launch of the device, which will begin in early August.

Key Points: 
  • The tri-axial system with braided shaft design facilitates stable and accurate implantation of the clinically proven Pulsar stent.
  • With its thin struts and low chronic outward force (COF)2,3,4the Pulsar-18 stent contributes to a reduced mean area of restenosis3,4.
  • The redesigned Pulsar-18 T3 stent system offers physicians an intuitive and ergonomic wheel-operated handle for one-handed stent release enhancing the ability to control deployment.
  • While the stent system has been redesigned with new features to enhance deployment, it builds on the established Pulsar stent performance.

Advanced NanoTherapies Announces Closing of Oversubscribed $7.2 Million Series A Financing

Retrieved on: 
Tuesday, June 28, 2022

LOS GATOS, Calif., June 28, 2022 /PRNewswire/ -- Advanced NanoTherapies, Inc., a privately-held medical device company committed to solving vascular disease's most significant challenges through the creative applications of nanotechnology, today announced the closing of its oversubscribed $7.2 million Series A equity financing, marking a total of $12.5 million raised since September 2020. Funds will be used to complete the first-in-human clinical study in Australia of the SirPlux Duo drug-coated balloon (DCB) in de-novo coronary artery disease (CAD) lesions. Funding comes from various sources in the U.S., Canada, Europe, and Asia.

Key Points: 
  • LOS GATOS, Calif., June 28, 2022 /PRNewswire/ -- Advanced NanoTherapies , Inc., a privately-held medical device company committed to solving vascular disease's most significant challenges through the creative applications of nanotechnology, today announced the closing of its oversubscribed $7.2 million Series A equity financing, marking a total of $12.5 million raised since September 2020.
  • "Interventional therapies have historically advanced in big steps angioplasty, bare-metal stenting, drug-eluting stenting," saysReggie Groves, Board of Directors Member at Advanced NanoTherapies.
  • We are pleased toinitiatethe next phase of Advanced NanoTherapies' clinical program."
  • Advanced NanoTherapies, Inc. is a highly specialized medical device company developing a nanoparticle technology-based platform for drug delivery.

$4+ Billion Peripheral Artery Disease Market - Global Opportunity Analysis and Industry Forecast, 2020-2022 & 2030 - ResearchAndMarkets.com

Retrieved on: 
Friday, June 10, 2022

The "Peripheral Artery Disease Market by Type, Global Opportunity Analysis and Industry Forecast, 2022 - 2030" report has been added to ResearchAndMarkets.com's offering.

Key Points: 
  • The "Peripheral Artery Disease Market by Type, Global Opportunity Analysis and Industry Forecast, 2022 - 2030" report has been added to ResearchAndMarkets.com's offering.
  • At an estimated value of over USD 4.02 billion in 2021, the Global Peripheral Artery Disease Market is predicted to thrive at a CAGR of 7.5% and valued at over USD 7.80 billion over the forecast year 2022-2030.
  • Peripheral artery disease is a common circulatory problem that causes narrowing of the peripheral arteries.
  • Straub Medical AG develops medical atherectomy & thrombectomy devices for the treatment of venous disease and peripheral arterial disease (PAD).

InspireMD Provides Highlights from Recent Presentations and Live Case Transmission at LINC 2022

Retrieved on: 
Thursday, June 9, 2022

TEL AVIV, Israel, June 09, 2022 (GLOBE NEWSWIRE) -- InspireMD, Inc. (Nasdaq: NSPR), developer of the CGuard Embolic Prevention System (EPS) for the prevention of stroke, today provided the following highlights from multiple presentations and live case transmission, all featuring its CGuard Embolic Prevention Stent System, from LINC 2022, which was held June 6-9.

Key Points: 
  • TEL AVIV, Israel, June 09, 2022 (GLOBE NEWSWIRE) -- InspireMD, Inc. (Nasdaq: NSPR), developer of the CGuard Embolic Prevention System (EPS) for the prevention of stroke, today provided the following highlights from multiple presentations and live case transmission, all featuring its CGuard Embolic Prevention Stent System, from LINC 2022, which was held June 6-9.
  • Of particular note, CGuard was featured in a very successful live case that clearly demonstrated the advantages of optimal vessel conformability with sustainable MicroNet mesh protection for best patient outcomes.
  • The patient was a 62 year old asymptomatic male with progressive and calcified internal carotid critical stenosis.
  • The procedure was successfully performed with the 10mm x 30mm CGuard EPS, obtaining an excellent angiographic result.

DynamX Bioadaptor Restores Rotational Motion and Vessel Stress Reduction in New Study

Retrieved on: 
Wednesday, June 1, 2022

The DynamX Bioadaptor is the first drug-eluting coronary artery implant that adapts to vessel physiology by incorporating flexible uncaging elements into its design.

Key Points: 
  • The DynamX Bioadaptor is the first drug-eluting coronary artery implant that adapts to vessel physiology by incorporating flexible uncaging elements into its design.
  • Computational modeling also indicated that peak rotational stress for the bioadaptor decreased by 70 percent with uncaging of the bioadaptor.
  • The DynamX Mechanistic Clinical Study previously showed that the bioadaptor enabled positive adaptive remodeling, preserving the vessel lumen to accommodate disease progression, as well as a return towards baseline vessel angulation and a strong safety profile.
  • This recent analysis now demonstrates the ability of the device to twist along with the vessels natural motion, and in doing so, subsequently reduce vessel stress.