Abbott recalls 2 coronary angioplasty catheters
Pharmaceutical and healthcare company Abbott Laboratories has issued a voluntary...Read more on AuntMinnie.comRelated Reading: FDA clears Abbott's ICD for use with MRI Abbott, CARO reach 10-year milestone Abbott to bring Xience V to China Abbott takes Xience Prime stent overseas Medtronic, Abbott bury patent-dispute hatchet (Source: AuntMinnie.com Headlines)
Source: AuntMinnie.com Headlines - February 25, 2020 Category: Radiology Source Type: news

Philips Seeks Better Understanding of PCI Outcomes Through New Trial
Philips is continuing its investment into percutaneous coronary intervention (PCI) procedures through a new study. The company announced the (Distal Evaluation of Functional performance with Intravascular sensors to assess the Narrowing Effect: Guided Physiologic Stenting) (DEFINE GPS) global multicenter study, which has a goal to assess outcomes of PCI procedures guided by integrated iFR and interventional X-ray images. The announcement of the study comes on the heels of Philips making a bid to shed its appliances unit so it can focus on healthcare.  The primary endpoint is target vessel failure (a composite o...
Source: MDDI - February 21, 2020 Category: Medical Devices Authors: Omar Ford Tags: Business Imaging Source Type: news

Polymer-Based Stents Noninferior for Patients With High Bleeding Risk
THURSDAY, Feb. 20, 2020 -- Polymer-based zotarolimus-eluting stents are noninferior to polymer-free drug-coated stents among patients at high bleeding risk undergoing percutaneous coronary intervention (PCI), according to a study published online... (Source: Drugs.com - Pharma News)
Source: Drugs.com - Pharma News - February 20, 2020 Category: Pharmaceuticals Source Type: news

Medtronic Begins New Pilot Study as Part of SPYRAL HTN Clinical Program for Renal Denervation in Hypertension Patients
Medtronic plc (NYSE:MDT) today announced it will begin enrollment in a pilot study evaluating the safety and efficacy of the Symplicity ™ Spyral renal denervation (RDN) system using a targeted procedural approach with a reduced number of radio frequency (RF) ablations. Set to enroll 50 patients at up to 15 sites in the U.S. and Europe, the single-arm study is designed to focus on ablating the distal main renal artery and primary b ranches to lower blood pressure utilizing a simplified procedural approach. (Source: News from Angioplasty.Org)
Source: News from Angioplasty.Org - February 4, 2020 Category: Cardiology Source Type: news

Biodegradable Coronary Stents Better Than Durable Stents in Registry Study Biodegradable Coronary Stents Better Than Durable Stents in Registry Study
Patients with acute myocardial infarction (MI) who underwent percutaneous coronary intervention (PCI) had better outcomes with biodegradable polymer drug-eluting stents (BP-DES) than with second-generation durable polymer drug-eluting stents (DP-DES), a South Korean registry study found.Reuters Health Information (Source: Medscape Medical News Headlines)
Source: Medscape Medical News Headlines - January 17, 2020 Category: Consumer Health News Tags: Cardiology News Source Type: news

U.S. Prices For Healthcare Services Far Outpace Peer Nations
The fact that angioplasties and hospital stays are much more expensive in the U.S. is not reflective of angioplasties or hospital stays being better in the U.S. Hospitals in the U.S. charge $32,000 for an angioplasty because they can in a market with non-competitive features. (Source: Forbes.com Healthcare News)
Source: Forbes.com Healthcare News - January 15, 2020 Category: Pharmaceuticals Authors: Joshua Cohen, Contributor Source Type: news

FDA offers guidance on angioplasty and specialty catheters
The U.S. Food and Drug Administration (FDA) has issued a draft guidance for...Read more on AuntMinnie.comRelated Reading: FDA offers guidance on coated devices Cinematic rendering offers clinical utility in MSK CT Coronary CTA beats stress test for changing lifestyles Medtronic launches new endoscopic catheter r4 Vascular gets FDA clearance for PTA balloon (Source: AuntMinnie.com Headlines)
Source: AuntMinnie.com Headlines - January 10, 2020 Category: Radiology Source Type: news

Today, the @US_FDA issued the draft guidance: Peripheral Percutaneous Transluminal Angioplasty (PTA) and Specialty Catheters – Premarket Notification (510(k)) Submissions.pic.twitter.com/UcPPibuz5y
Today, the @US_FDA issued the draft guidance: Peripheral Percutaneous Transluminal Angioplasty (PTA) and Specialty Catheters – Premarket Notification (510(k)) Submissions. pic.twitter.com/UcPPibuz5y (Source: Food and Drug Adminstration (FDA): CDRHNew)
Source: Food and Drug Adminstration (FDA): CDRHNew - January 10, 2020 Category: Medical Devices Authors: ( at FDADeviceInfo) Source Type: news

Peripheral percutaneous transluminal angioplasty (PTA) balloons and specialty catheters are devices intended to treat lesions in the peripheral vascular system.
(Source: Food and Drug Adminstration (FDA): CDRHNew)
Source: Food and Drug Adminstration (FDA): CDRHNew - January 10, 2020 Category: Medical Devices Authors: ( at FDADeviceInfo) Source Type: news

Clopidogrel Appropriate for PCI in Liver Transplant Candidates Clopidogrel Appropriate for PCI in Liver Transplant Candidates
In patients with decompensated cirrhosis undergoing percutaneous coronary intervention (PCI), clopidogrel safely inhibits platelet aggregation, according to a small study of liver-transplant candidates.Reuters Health Information (Source: Medscape General Surgery Headlines)
Source: Medscape General Surgery Headlines - January 8, 2020 Category: Surgery Tags: Cardiology News Source Type: news

Percutaneous Coronary Intervention (PCI)
Title: Percutaneous Coronary Intervention (PCI)Category: Procedures and TestsCreated: 12/31/1997 12:00:00 AMLast Editorial Review: 1/3/2020 12:00:00 AM (Source: MedicineNet Heart General)
Source: MedicineNet Heart General - January 3, 2020 Category: Cardiology Source Type: news

Welcome Data Show Two Sides of PCI in Patients With Cancer Welcome Data Show Two Sides of PCI in Patients With Cancer
Although more patients with cancer are living longer and are undergoing percutaneous coronary intervention, data are scarce on contemporary stent performance.Medscape Medical News (Source: Medscape General Surgery Headlines)
Source: Medscape General Surgery Headlines - December 31, 2019 Category: Surgery Tags: Cardiology News Source Type: news

In the U.S., an angioplasty costs $32,000. Elsewhere? Maybe $6,400.
As politicians continue to lament the system ’s expense, and more Americans struggle to pay the high and often unpredictable bills that can accompany their health problems, it’s worth looking at just how weird our prices really are relative to the rest of the world. (Source: bizjournals.com Health Care:Pharmaceuticals headlines)
Source: bizjournals.com Health Care:Pharmaceuticals headlines - December 27, 2019 Category: Pharmaceuticals Authors: Margot Sanger-Katz Source Type: news

In the U.S., an Angioplasty Costs $32,000. Elsewhere? Maybe $6,400.
A study of international prices finds American patients pay much more across a wide array of common services. (Source: NYT)
Source: NYT - December 27, 2019 Category: American Health Authors: Margot Sanger-Katz Tags: Prices (Fares, Fees and Rates) Health Insurance and Managed Care Presidential Election of 2020 Hospitals Source Type: news

20 Private Companies to Watch in 2020
MD+DI has taken a hard look at the private medtech sector and developed this list of 20 private companies we will be paying particularly close attention to in the new year. It was not an easy task. There are so many interesting private companies in the industry right now that we started with a much longer list and whittled it down to the 20 companies that stood out most to us. So without further ado, here are the 20 companies that made the cut: 4C Medical is developing the AltaValve, a transcatheter mitral valve replacement (TMVR) platform designed to address mitr...
Source: MDDI - December 24, 2019 Category: Medical Devices Authors: Amanda Pedersen Tags: Business Source Type: news

20 Private Medtech Companies to Watch in 2020
MD+DI has taken a hard look at the private medtech sector and developed this list of 20 private companies we will be paying particularly close attention to in the new year. It was not an easy task. There are so many interesting private companies in the industry right now that we started with a much longer list and whittled it down to the 20 companies that stood out most to us. So without further ado, here are the 20 companies that made the cut: 4C Medical is developing the AltaValve, a transcatheter mitral valve replacement (TMVR) platform designed to address mitr...
Source: MDDI - December 24, 2019 Category: Medical Devices Authors: Amanda Pedersen Tags: Business Source Type: news

University Hospital Giessen Performs First Minimally Invasive, Robotic-Assisted Coronary Intervention in Germany
The University Hospital Giessen is the first hospital in Germany where a robotic system assists in a minimally invasive procedure to place a stent into a narrowed coronary artery to reopen it. This percutaneous coronary intervention (PCI) was carried out by the team of Prof. Holger Nef, Deputy Clinical Director Medical Clinic I, Cardiology and Angiology, University Giessen. (Source: eHealth News EU)
Source: eHealth News EU - December 18, 2019 Category: Information Technology Tags: Featured Siemens Healthineers Business and Industry Source Type: news

Can 3D Modeling Replace a Guidewire-Based Cardiac Procedure?
The CathWorks FFRangio System, which received FDA clearance in late last year, has just been approved by the Japan's Ministry of Health, Labour and Welfare (MHLW). Designed for use during angiography, the non-invasive diagnostic tool turns routine angiogram images into color-coded 3D renderings of blood flow in the heart's arteries. Physicians can then use the images to determine whether a stent is needed. “The CathWorks FFRangio System automatically receives the angiograms in DiCOM format from the C-ARM (X-Ray) systems at the time of angiogram procedure,” Ramin Mousavi, vice president,&...
Source: MDDI - December 17, 2019 Category: Medical Devices Authors: Daphne Allen Tags: Cardiovascular Source Type: news

5 More Private Medtech Companies to Keep Tabs On
MedTech analysts continue to keep a watchful eye on the private sector. Needham & Co.'s Mike Matson recently called attention to five private medical device companies he finds interesting, adding to three previous lists the analyst published earlier this year. Matson was not the only medtech analyst keeping tabs on up and coming private companies in 2019. In January, Canaccord Genuity's Jason Mills highlighted 16 potentially disruptive medtech companies in the private sector. Here are the five companies Matson most recently highlighted. 7D Surgical...
Source: MDDI - December 16, 2019 Category: Medical Devices Authors: Amanda Pedersen Tags: Business Source Type: news

Many Patients Overestimate the Benefits of PCI
MONDAY, Dec. 9, 2019 -- Many patients do not understand or remember the information given to them during the informed consent process for percutaneous coronary intervention (PCI), according to a study published online Nov. 27 in the European Journal... (Source: Drugs.com - Pharma News)
Source: Drugs.com - Pharma News - December 9, 2019 Category: Pharmaceuticals Source Type: news

Medical News Today: What to know about angioplasty
Angioplasty is a medical procedure that opens a blocked or narrowed artery close to the heart. Learn about the procedure, the types, recovery, and risks here. (Source: Health News from Medical News Today)
Source: Health News from Medical News Today - November 28, 2019 Category: Consumer Health News Tags: Cardiovascular / Cardiology Source Type: news

Angioplasty and Stents
Title: Angioplasty and StentsCategory: Procedures and TestsCreated: 12/31/1997 12:00:00 AMLast Editorial Review: 11/26/2019 12:00:00 AM (Source: MedicineNet Heart General)
Source: MedicineNet Heart General - November 26, 2019 Category: Cardiology Source Type: news

New model for predicting kidney injury after common heart procedure
Exposure to contrast agents during angioplasty puts patients at risk of kidney damage. Yale researchers have developed a tool to minimize that risk. (Source: Yale Science and Health News)
Source: Yale Science and Health News - November 22, 2019 Category: Universities & Medical Training Source Type: news

Medtronic FDA Approval Marks a Turnaround in the Paclitaxel Story
Paclitaxel-coated balloons and paclitaxel-eluting stents caused quite the stir for manufacturers and physicians this year, but an FDA approval this week marks a major step forward for this category of devices. The agency approved Medtronic's IN.PACT AV drug-coated balloon for the treatment of failing arteriovenous access in patients with end-stage renal disease (ESRD) undergoing dialysis. AV fistulae are created and used to enable hemodialysis for patients with ESRD. Over time, vessel restenosis limits the ability to use AV fistulae effectively. In order to restore function, patients often undergo one to three ...
Source: MDDI - November 22, 2019 Category: Medical Devices Authors: Amanda Pedersen Tags: Cardiovascular Source Type: news

AHA: Impella Use Up for PCI Patients Needing Heart Pump
THURSDAY, Nov. 21, 2019 -- Impella use is increasing for percutaneous coronary intervention (PCI) patients treated with mechanical circulatory support (MCS), although its use is associated with adverse events, according to a study published online... (Source: Drugs.com - Pharma News)
Source: Drugs.com - Pharma News - November 21, 2019 Category: Pharmaceuticals Source Type: news

LimFlow Shows ‘PROMISE’ During VIVA
A firm that was labeled one of Medtech’s 16 Most Promising Private Companies by Canaccord Genuity earlier this year, has strong results from a study that will help with FDA approval. LimFlow recently announced positive six-month data from the full patient cohort in its PROMISE I early feasibility study of the Percutaneous Deep Vein Arterialization (pDVA) System. The Paris-based company presented the data during the Vascular Interventional Advances [VIVA] Conference held in Las Vegas, earlier this month. The company’s technology is used for the treatment of chronic limb-threatening ischem...
Source: MDDI - November 18, 2019 Category: Medical Devices Authors: Omar Ford Tags: Cardiovascular Source Type: news

Study Casts Doubt on Angioplasty, Bypass for Many Heart Patients
However, the results of a large and long-awaited clinical trial suggests that, in most cases, these procedures may not have provided any benefit over medications and lifestyle changes. (Source: WebMD Health)
Source: WebMD Health - November 18, 2019 Category: Consumer Health News Source Type: news

Cheap, Older Gout Drug Could Be a Lifesaver After Heart Attack
In the new trial, colchicine reduced by as much as 34% a heart attack survivor's combined risk of either dying from heart disease or having cardiac arrest, a heart attack, a stroke or angioplasty. (Source: WebMD Health)
Source: WebMD Health - November 18, 2019 Category: Consumer Health News Source Type: news

Study Casts Doubt on Angioplasty, Bypass for Many Heart Patients
Title: Study Casts Doubt on Angioplasty, Bypass for Many Heart PatientsCategory: Health NewsCreated: 11/17/2019 12:00:00 AMLast Editorial Review: 11/18/2019 12:00:00 AM (Source: MedicineNet Heart General)
Source: MedicineNet Heart General - November 18, 2019 Category: Cardiology Source Type: news

Study Casts Doubt on Angioplasty, Bypass for Many Heart Patients
SUNDAY, Nov. 17, 2019 -- Bypass operations, angioplasty and the placement of artery-opening stents: For decades, millions of Americans have undergone these expensive, invasive procedures to help treat clogged vessels. However, the results of a large... (Source: Drugs.com - Daily MedNews)
Source: Drugs.com - Daily MedNews - November 17, 2019 Category: General Medicine Source Type: news

Big Study Finds Many Heart Procedures Won ’t Cut Risk of Having Heart Attack
This study clearly goes against what has been the common wisdom for the last 30, 40 years” and may lead to less testing and invasive treatment for such patients in the future, said Dr. Glenn Levine, a Baylor College of Medicine cardiologist with no role in the research. Some doctors still may quibble with the study, but it was very well done “and I think the results are extremely believable,” he said. About 17 million Americans have clogged arteries that crimp the heart’s blood supply, which can cause periodic chest pain. Cheap and generic aspirin, cholesterol-lowering drugs and blood pressure medic...
Source: TIME: Health - November 16, 2019 Category: Consumer Health News Authors: ARILYNN MARCHIONE / AP Tags: Uncategorized onetime Research Source Type: news

Boston Scientific Touts Positive Data on Two Paclitaxel Devices
Boston Scientific announced positive data Tuesday for two paclitaxel devices during separate late-breaking clinical trial presentations at the annual Vascular InterVentional Advances (VIVA) meeting in Las Vegas. Paclitaxel-coated balloons and paclitaxel-eluting stents caused quite the stir for the drug-coated balloon manufacturers and physicians this year, but presentations like these could go a long way toward helping the market rebound. To recap, paclitaxel balloons and stents received some bad press in late December 2018 after a meta-analysis showed...
Source: MDDI - November 5, 2019 Category: Medical Devices Authors: Amanda Pedersen Tags: Cardiovascular Source Type: news

12 Innovations That Will Change Health Care and Medicine in the 2020s
Pocket-size ultrasound devices that cost 50 times less than the machines in hospitals (and connect to your phone). Virtual reality that speeds healing in rehab. Artificial intelligence that’s better than medical experts at spotting lung tumors. These are just some of the innovations now transforming medicine at a remarkable pace. No one can predict the future, but it can at least be glimpsed in the dozen inventions and concepts below. Like the people behind them, they stand at the vanguard of health care. Neither exhaustive nor exclusive, the list is, rather, representative of the recasting of public health and medic...
Source: TIME: Health - October 25, 2019 Category: Consumer Health News Authors: TIME Staff Tags: Uncategorized HealthSummit19 technology Source Type: news

PCI, CABG for Left Main CAD Have Similar Five-Year Outcomes
FRIDAY, Oct. 4, 2019 -- Five-year rates of a composite outcome of death, stroke, and myocardial infarction are similar for patients with left main coronary artery disease following either percutaneous coronary intervention (PCI) or coronary artery... (Source: Drugs.com - Pharma News)
Source: Drugs.com - Pharma News - October 4, 2019 Category: Pharmaceuticals Source Type: news

No Increased Mortality With Paclitaxel Balloon Angioplasty in PAD No Increased Mortality With Paclitaxel Balloon Angioplasty in PAD
A new patient-level aggregate dataset from the LEVANT trials shows no increase in mortality for patients treated with paclitaxel-coated balloon angioplasty at 5 years of follow-up.Medscape Medical News (Source: Medscape Cardiology Headlines)
Source: Medscape Cardiology Headlines - October 2, 2019 Category: Cardiology Tags: Cardiology News Source Type: news

Less Bleeding With Ticagrelor Alone in High-Risk Patients
FRIDAY, Sept. 27, 2019 -- Ticagrelor alone results in less bleeding than ticagrelor plus aspirin among high-risk patients who have undergone percutaneous coronary intervention (PCI) and received dual antiplatelet therapy for three months, according... (Source: Drugs.com - Pharma News)
Source: Drugs.com - Pharma News - September 27, 2019 Category: Pharmaceuticals Source Type: news

First & #039;Artificial Meniscus & #039; Wins FDA Breakthrough Device Designation
U.S. patients who continue to suffer from knee pain after meniscus surgery, but are too young for total knee replacement may soon have a new treatment option. FDA has granted Active Implants' NUsurface meniscus implant a breakthrough device designation. The artificial meniscus device is already available in Europe and, if cleared by FDA, would also be the first artificial meniscus in the United States.  Earlier this year Active Implants gained some attention from Needham & Co.'s Mike Matson, who included the company on a list of interesting private medtech companies.&Acir...
Source: MDDI - September 19, 2019 Category: Medical Devices Authors: Amanda Pedersen Tags: Orthopedics Source Type: news

Short DAPT After DES: P2Y12 Monotherapy in, Aspirin out! Short DAPT After DES: P2Y12 Monotherapy in, Aspirin out!
A new study addresses the question of when aspirin can be safely discontinued in higher risk patients such as those undergoing complex percutaneous coronary intervention.European Heart Journal (Source: Medscape Today Headlines)
Source: Medscape Today Headlines - September 18, 2019 Category: Consumer Health News Tags: Cardiology Journal Article Source Type: news

Government to drop 500 existing health packages, include 250 new ones
The discontinued packages include renal angioplasty with single stent (medicated) and eversion of hydrocele sac — unilateral. (Source: The Economic Times)
Source: The Economic Times - September 18, 2019 Category: Consumer Health News Source Type: news

Expert Alert: Study finds repeat coronary artery bypass grafting improves long-term survival
ROCHESTER, Minn. ?-- When a coronary artery bypass grafting (CABG) patient needs a second surgery because of recurrent chest pain, more often than not it's a percutaneous coronary intervention (PCI), commonly known as coronary angioplasty with stents. A study published in September in Mayo Clinic Proceedings says that a better option may be repeating the [...] (Source: News from Mayo Clinic)
Source: News from Mayo Clinic - September 18, 2019 Category: Databases & Libraries Source Type: news

Orchestra & #039;s Drug-Eluting Balloon Wins FDA Breakthrough Device Designation
FDA has granted a breakthrough device designation for Orchestra BioMed's Virtue sirolimus-eluting balloon (SEB) in the treatment of below-the-knee (BTK) peripheral artery disease. The designation comes just a few months after the New Hope, PA-based announced its partnership with Terumo. The agreement included a $30 million up-front payment to Orchestra plus an equity commitment of $5 million. Virtue SEB is a novel, first-in-class drug/device combination product that delivers a sustained-release sirolimus formulation directly to the artery during balloon angioplasty without the need for a coating. Breakthrough d...
Source: MDDI - September 17, 2019 Category: Medical Devices Authors: Amanda Pedersen Tags: Cardiovascular Source Type: news

Shockwave Gets a Little Pep in Its Step with Breakthrough Device Designation
The regulatory pathway for Shockwave Medical’s Intravascular Lithotripsy (IVL) technology just received a huge jolt from FDA. The agency granted the Santa Clara, CA-based company breakthrough device designation for the Shockwave IVL System with the Shockwave C2 Coronary IVL Catheter. The firm’s device is designed to fracture problematic calcium using sonic pressure to facilitate stent delivery, deployment, and optimal expansion, thereby improving blood flow to the heart muscle. Shockwave’s technology is being evaluated in the DISRUPT CAD III, a prospective, non-randomiz...
Source: MDDI - September 4, 2019 Category: Medical Devices Authors: Omar Ford Tags: Regulatory and Compliance Cardiovascular Source Type: news

In STEMI, Biodegradable Polymer Sirolimus-Eluting Stents Superior
TUESDAY, Sept. 3, 2019 -- For patients with ST-segment elevation myocardial infarction (STEMI) undergoing primary percutaneous coronary intervention (PCI), there were fewer target lesion failures at one year in those receiving biodegradable polymer... (Source: Drugs.com - Pharma News)
Source: Drugs.com - Pharma News - September 3, 2019 Category: Pharmaceuticals Source Type: news

Complete Revascularization Best for STEMI With Multivessel CAD
TUESDAY, Sept. 3, 2019 -- For patients with ST-segment elevation myocardial infarction (STEMI) and multivessel coronary artery disease, complete revascularization is superior to culprit lesion-only percutaneous coronary intervention (PCI), according... (Source: Drugs.com - Pharma News)
Source: Drugs.com - Pharma News - September 3, 2019 Category: Pharmaceuticals Source Type: news

Another Breakthrough Designation for Concept Medical
Concept Medical’s MagicTouch AVF might have the “magic touch” when it comes down to nabbing breakthrough device designations. The proposed indication for the latest breakthrough device designation is for the treatment of stenotic lesions of Arteriovenous Fistulae or Arteriovenous graft in the hemodialysis treatment of renal failure. Concept Medical said its first pilot study to investigate the safety and efficacy of Magic Touch PTA Sirolimus balloon was started in Singapore in 2018. Led by Principal Investigator, Dr. Tan Chieh Suai, a multi-disciplinary team of doctors ...
Source: MDDI - September 3, 2019 Category: Medical Devices Authors: Omar Ford Tags: Cardiovascular Source Type: news

Early after routine heart procedures, other operations become riskier
(Reuters Health) - Patients who have so-called percutaneous coronary intervention (PCI) procedures to restore blood flow to the heart may be more likely to have complications with non-cardiac surgery than other people, a U.S. study suggests. (Source: Reuters: Health)
Source: Reuters: Health - August 30, 2019 Category: Consumer Health News Tags: healthNews Source Type: news

Pollution causes rates of angioplasties to spiral, say scientists
Doctors at the University Hospital in Krakow used data from nearly 16,000 patients who had undergone the operation, which is often dished out as an emergency surgery to treat a heart attack. (Source: the Mail online | Health)
Source: the Mail online | Health - August 23, 2019 Category: Consumer Health News Source Type: news

August Is Hot with New FDA Breakthrough Device Designations
V-Wave is joining the growing list of companies that have been granted breakthrough device designation by FDA this month. The Caesarea, Israel-based company gained the designation for its interatrial shunt for heart failure. Miniature and minimally invasive, the interatrial shunt relieves increased left atrial pressure, which in turn, decreases fluid build-up in the lungs. “The interatrial shunt allows a small amount of blood volume from the left side of the heart to flow into the right side of the heart,” Murtaza Mogri, PhD Director, Business Development & Market Access V-Wave, tol...
Source: MDDI - August 16, 2019 Category: Medical Devices Authors: Omar Ford Tags: Cardiovascular Business Source Type: news

Concept Medical Has the ‘MagicTouch’ to Treat PAD
Concept Medical just received a huge burst of speed in its quest to get its drug-coated balloon for the treatment of peripheral artery disease (PAD) commercially available in the U.S. The Tampa, FL-based company has received breakthrough device designation from FDA for the MagicTouch PTA, a Sirolimus drug-coated balloon (DCB) catheter, for the treatment of Peripheral Artery Disease (PAD) in Below-the-Knee (BTK). So far, Concept Medical said MagicTouch has been performing extremely well. In the XTOSI pilot study, the majority of patients enrolled had major comorbidities (diabetes and end-stage renal failure) and the indicat...
Source: MDDI - August 14, 2019 Category: Medical Devices Authors: Omar Ford Tags: Cardiovascular Source Type: news

Patel-backed company gets FDA designation for product that could reduce leg amputations
A company backed by serial Tampa Bay entrepreneur Dr.  Kiran Patel has secured a key designation that will help advance a product from the medical device company. Concept Medical Inc. has been granted "Breakthrough Device Designation" from the U.S. Food and Drug Administration for MagicTouch Percutaneous Transluminal Angioplasty, which is a Sirolimu s drug coated balloon catheter, for the treatment of peripheral artery disease. The device is for a disease that takes place below the knee, also… (Source: bizjournals.com Health Care:Pharmaceuticals headlines)
Source: bizjournals.com Health Care:Pharmaceuticals headlines - August 12, 2019 Category: Pharmaceuticals Authors: Veronica Brezina-Smith Source Type: news