Medtech approvals: FDA releases December 2015 PMAs
The Food & Drug Administration today released a list of pre-market approvals granted in December 2015:
Summary of PMA Originals & Supplements Approved
Originals: 2
Supplements: 81
Summary of PMA Originals Under Review
Total Under Review: 58
Total Active: 32
Total On Hold: 26
Summary of PMA Supplements Under Review
Total Under Review: 599
Total Active: 423
Total On Hold: 176
Summary of All PMA Submissions
Originals: 3
Supplements: 92
Summary of PMA Supplement PMA Approval/Denial Decision Times
Number of Approvals: 81
Number of Denials: 0
Average Days Fr Receipt to Decision (Total Time): 163.1
FDA Time: 140....
Source: Mass Device - February 2, 2016 Category: Medical Equipment Authors: MassDevice Tags: Food & Drug Administration (FDA) Regulatory/Compliance Source Type: news
Biotronik expands DCB line with CE Mark for Passeo-18 Lux
Biotronik said today it won CE Mark approval in the European Union for smaller sizes of its Passeo-18 Lux drug-coated balloon designed for treating peripheral arterial disease, specifically de novo and restenotic lesions in the infrainguinal arteries.
The device is now cleared in 2 mm and 2.5 mm sizes to facilitate treatment of below-the-knee arteries. Approval for the device was based on the randomized, controlled Biolux P-I clinical trial, with results published in the Journal of Endovascular Therapy.
“Effective treatment of infrapopliteal arterial disease is quite challenging as it involves high-risk patients wit...
Source: Mass Device - January 26, 2016 Category: Medical Equipment Authors: Fink Densford Tags: Catheters Drug-Device Combinations Regulatory/Compliance Vascular Biotronik Source Type: news
Medtech approvals: FDA releases November 2015 PMAs
The FDA today released its list of the pre-market approvals it granted for medical devices in November 2015:
Summary of PMA Originals & Supplements Approved
Originals: 3
Supplements: 69
Summary of PMA Originals Under Review
Total Under Review: 57
Total Active: 30
Total On Hold: 27
Summary of PMA Supplements Under Review
Total Under Review: 583
Total Active: 433
Total On Hold: 150
Summary of All PMA Submissions
Originals: 4
Supplements: 75
Summary of PMA Supplement PMA Approval/Denial Decision Times
Number of Approvals: 69
Number of Denials: 0
Average Days Fr Receipt to Decision (Total Time): 193.4
FDA Time: 1...
Source: Mass Device - January 22, 2016 Category: Medical Equipment Authors: MassDevice Tags: Food & Drug Administration (FDA) Regulatory/Compliance Source Type: news
Medtronic wins CE Mark for In.Pact Admiral DCB for end-stage renal disease
Medtronic (NYSE:MDT) said today its In.Pact admiral drug eluting balloon won CE Mark approval in the European Union for arteriovenous access to help maintain hemodialysis access in patients with end-stage renal disease.
The device is now cleared for preventing restenosis in hemodialysis access sites by opening up the artery and delivering paclitaxel to the vessel wall. A 40 cm catheter shaft will also be made available alongside the expanded indication for the device.
“For patients with hemodialysis, maintaining AV access is their lifeline to receiving the care they need to filter waste from their system. In the pa...
Source: Mass Device - January 11, 2016 Category: Medical Equipment Authors: Fink Densford Tags: Catheters Drug-Device Combinations Regulatory/Compliance Vascular Medtronic Source Type: news
Medtech approvals: FDA releases October 2015 PMAs
The FDA today released its list of the pre-market approvals it granted for medical devices in October 2015:
Summary of PMA Originals & Supplements Approved
Originals: 9
Supplements: 133
Summary of PMA Originals Under Review
Total Under Review: 58
Total Active: 32
Total On Hold: 26
Summary of PMA Supplements Under Review
Total Under Review: 597
Total Active: 433
Total On Hold: 164
Summary of All PMA Submissions
Originals: 7
Supplements: 74
Summary of PMA Supplement PMA Approval/Denial Decision Times
Number of Approvals: 133
Number of Denials: 0
Average Days Fr Receipt to Decision (Total Time): 161.5
FDA Time: ...
Source: Mass Device - December 4, 2015 Category: Medical Equipment Authors: Brad Perriello Tags: Food & Drug Administration (FDA) Regulatory/Compliance Source Type: news
SurModics picks up Creagh Medical for $32m
SurModics (NSDQ:SRDX) said today it acquired percutaneous transluminal angioplasty balloon catheter developer and manufacturer Creagh Medical for $32 million.
The acquisition included an upfront payment of $19 million (€18 million) and a possible $12.8 million (€12 million) based on milestones and revenue achievements. Other terms of the deal were not disclosed.
“We are excited about the acquisition of Creagh Medical and the strategic fit of its balloon catheter design and development, and manufacturing capabilities, which are critical to our transformation into a whole-product solutions provider. We are discipli...
Source: Mass Device - November 20, 2015 Category: Medical Equipment Authors: Fink Densford Tags: Business/Financial News Catheters Mergers & Acquisitions Creagh Medical SurModics Inc. Source Type: news
Medtronic touts In.Pact Admiral DCB data
Medtronic (NYSE:MDT) today touted data from a pair of studies of its In.Pact Admiral drug-coated balloon, presented today at the annual Vascular Interventional Advances conference in Las Vegas.
Researchers revealed the formal cost-effectiveness analysis of the U.S. cohort of Medtronic’s In.Pact SFA trial, and in-stent restenosis cohort data from its In.Pact Global study.
Medtronic said the 2-year, prospective cost-effectiveness study of 181 patients showed that, although treatment with the drug-coated balloon was more expensive than with standard percutaneous transluminal angioplasty, costs were actually $100 lowe...
Source: Mass Device - November 2, 2015 Category: Medical Equipment Authors: Brad Perriello Tags: Clinical Trials Drug-Eluting Balloons Medtronic Peripheral Artery Disease Vascular Interventional Advances (VIVA) Source Type: news
TCT 2015: Two-year results from Medtronic’s In.Pact SFA trial
Two-year results from Medtronic‘s (NYSE:MDT) In.Pact SFA study showed that the drug-eluting balloon was better than conventional balloon angioplasty, researchers said today at the annual Transcatheter Cardiovascular Therapeutics conference in San Francisco.
The 331-patient study randomized subjects 2:1 to either treatment with Medtronic’s In.Pact Admiral DEB or standard angioplasty. The primary efficacy endpoint was primary patency, while the primary safety endpoint was a composite of freedom from device- and procedure-related death after 30 days and freedom from target limb major amputation and clinically-d...
Source: Mass Device - October 14, 2015 Category: Medical Equipment Authors: Brad Perriello Tags: Cardiovascular Drug-Eluting Balloons Medtronic TCT 2015 Source Type: news
Medtech approvals: FDA releases June 2015 PMAs
The FDA today released its list of the pre-market approvals it granted for medical devices in June 2015:
Summary of PMA Originals & Supplements Approved
Originals: 5
Supplements: 80
Summary of PMA Originals Under Review
Total Under Review: 53
Total Active: 22
Total On Hold: 31
Summary of PMA Supplements Under Review
Total Under Review: 575
Total Active: 418
Total On Hold: 157
Summary of All PMA Submissions
Originals: 4
Supplements: 72
Summary of PMA Supplement PMA Approval/Denial Decision Times
Number of Approvals: 80
Number of Denials: 0
Average Days Fr Receipt to Decision (Total Time): 115.2
FDA Time: 97.1 ...
Source: Mass Device - August 20, 2015 Category: Medical Equipment Authors: MassDevice Tags: Food & Drug Administration (FDA) Regulatory/Compliance Source Type: news
Bard touts publication of Lutonix study in NEJM
C.R. Bard (NYSE:BCR) said last Thursday that a 2-year study of its Lutonix drug-coated balloon catheter was published in The New England Journal of Medicine.
The 2-year Levant 2 study data showed non-inferiority of the device and a trend towards superiority, compared to standard percutaneous transluminal angioplasty, in the treatment of peripheral artery disease, the company said.
“We want to thank the investigators involved in the Levant 2 trial for their authorship of this ground-breaking study. Publication of the study results in The New England Journal of Medicine demonstrates the high quality of the trial ...
Source: Mass Device - June 29, 2015 Category: Medical Equipment Authors: Fink Densford Tags: Catheters Clinical Trials Vascular C.R. Bard New England Journal of Medicine Source Type: news
Bard touts 2-year data on Lutonix
C.R. Bard (NYSE:BCR) said that data from a 2-year study of its Lutonix drug-coated balloon catheter showed positive results for the device when compared to standard percutaneous transluminal angioplasty.
The 2-year Levant study data showed non-inferiority of the device and a trend towards superiority compared to standard PTA, the company said. Composite safety scores at 24 months were 78.7% for Lutonix, versus 70.9% for standard PTA.
Primary patency, or the rate of lesion reoccurrence, was at 58.6% with Lutonix vs 53% with standard PTA, the study reports. The difference shows a 10.5% relative increase for the Lutonix devic...
Source: Mass Device - June 19, 2015 Category: Medical Equipment Authors: Fink Densford Tags: Cardiovascular Clinical Trials C.R. Bard Lutonix Inc. Source Type: news
MassDevice.com +3 | The top 3 medtech stories for June 12, 2015
Say hello to MassDevice +3, a bite-sized view of the top three medtech stories of the day. This feature of MassDevice.com’s coverage highlights our 3 biggest and most influential stories from the day’s news to make sure you’re up to date on the headlines that continue to shape the medical device industry.
3. Sorin, Cyberonics announce new slate for post-merger board
Sorin Group and Cyberonics announced a new slate for the board of directors that will oversee the company after the expected close of their $1.4 billion merger in the 3rd quarter.
Last month the companies announced the management roste...
Source: Mass Device - June 15, 2015 Category: Medical Equipment Authors: Melissa Annand Tags: News Well Source Type: news
Medtronic Initiates U.S. Launch of Fortrex™ PTA Balloon
Medtronic plc (NYSE: MDT) announced today the launch of the Fortrex™ over-the-wire (OTW) percutaneous transluminal angioplasty (PTA) balloon catheter. The Fortrex PTA balloon catheter utilizes a high pressure balloon to break up the blockages and open the vessels to help maintain arteriovenous (AV) access in the peripheral vascular system. (Source: News from Angioplasty.Org)
Source: News from Angioplasty.Org - June 14, 2015 Category: Cardiology Source Type: news
Medtronic launches Fortrex PTA balloon catheter in US
Medtronic (NYSE:MDT) said yesterday that it launched its Fortrex percutaneous transluminal angioplasty balloon catheter in the U.S.
The Fortrex is designed to treat peripheral artery disease and maintain arteriovenous access for hemodialysis, the Fridley, Minn.-based company said. The catheter uses a balloon to break up plaque blockages in the peripheral vascular system, or blockages in hemodialysis patients at the dialysis sites, the company added.
“Being able to maintain AV access for patients receiving hemodialysis for renal disease and kidney failure is critical as it is a patient’s lifeline. In the past, ...
Source: Mass Device - June 11, 2015 Category: Medical Equipment Authors: Fink Densford Tags: Cardiovascular Catheters medtronic Source Type: news
MassDevice.com +3 | The top 3 medtech stories for June 10, 2015
Say hello to MassDevice +3, a bite-sized view of the top three medtech stories of the day. This feature of MassDevice.com’s coverage highlights our 3 biggest and most influential stories from the day’s news to make sure you’re up to date on the headlines that continue to shape the medical device industry.
3. Battelle pairs with Feinstein Institute to develop ‘neural tourniquet’
Battelle said that it’s partnering with the Feinstein Institute to develop a novel “neural tourniquet” designed to staunch blood loss using neurostimulation.
The device functions by electrical...
Source: Mass Device - June 10, 2015 Category: Medical Equipment Authors: MassDevice Tags: News Well Plus 3 Source Type: news
