Cardiovascular Systems, Chansu Vascular Technologies partner to develop drug-coated balloons

Cardiovascular Systems recently announced that it has partnered with Chansu Vascular Technologies to develop a new drug-coated balloon technology.

Through the partnership, Cardiovascular Systems and Chansu Vascular Technologies will develop peripheral and coronary everolimus drug-coated balloons. Cardiovascular Systems will provide milestone-based financing to Chansu Vascular Technologies for the development of the drug-coated balloons. The deal also includes an acquisition option agreement in which Cardiovascular Systems will have exclusive rights and obligations to acquire the company upon completion of key technical and clinical milestones in the development program.

“This partnership is consistent with our strategic vision to develop an innovative portfolio of new products. We believe these next generation DCBs will complement our current and growing portfolio of products for the treatment of complex coronary and peripheral disease. We are thrilled to be wo…

Read more
  • 0

Smart urinary catheter company moves to Minneapolis, changes its name to UroDev

UroDev Medical, formerly known as Spinal Singularity, this week announced it appointed Matt Monarski as CEO and that it would be moving its headquarters to Minneapolis.

Monarski joins the company with nearly 30 years of global commercial experience focused on advancing new urology, gynecology and orthopedic medical devices. Prior to joining the company, Monarski held numerous leadership roles at NeoTract and Teleflex, where he was responsible for driving the adoption of the company’s UroLift System. He has also held numerous marketing and sales roles at American Medical Systems and Tornier.

“UroDev Medical is poised to successfully address a condition that affects millions of men in the U.S., and I couldn’t be more excited to join this team during this critical time in the company’s evolution,” said Monarski. “I believe in the potential of this disruptive technology to fill a growing clinical need in the urology space, and I look forward to leading the co…

Read more
  • 0

FDA: Penumbra recall of some Jet 7 catheters is serious

A Penumbra recall of certain Jet 7 catheters is Class I – the most serious type of recall, the FDA recently said.

The recall, which Penumbra originally announced on Dec. 15, 2020, involved more than 30,000 distributed units of its Jet 7 Reperfusion Catheters with Xtra Flex Technology after the company received 14 reports of death related to the device. Penumbra distributed the devices between June 17, 2019 and Dec. 14, 2020.

Some Jet 7 catheters pose the risk of unexpected death or serious injury while used for removing clots in stroke patients. Distal tip damage with pressurization or contrast injection could result in potential vessel damage and patient injury or death.

The FDA said in December that it received over 200 medical device reports associated with the catheter, which included deaths, serious injuries and malfunctions, according to the FDA letter warning healthcare providers. The FDA at the time said 20 of the MDRs described 14 unique patient…

Read more
  • 0

Medtronic touts recently acquired Rist catheters for neurovascular procedures

Medtronic today announced an early site limited release of its recently acquired Rist radial access guide catheters.

The Rist 079 catheter is designed for the introduction of interventional devices into the peripheral, coronary and neuro vasculature using the radial artery in the wrist. The Rist Radial Access Selective Catheter is designed to introduce interventional devices into the peripheral, coronary and neuro vasculature and can facilitate the introduction of diagnostic agents in the neuro vasculature.

“Rist 079 Radial Access Guide catheter is the first catheter that has been specifically designed for neurointerventions using the radial artery pathway in the wrist. This is the first-of-its-kind device that optimizes transition zones for the required navigability and support that is unique to the radial trajectory when compared to the femoral approach,” Webster Crowley, chief of cerebrovascular and endovascular neurosurgery at Rush University Me…

Read more
  • 0

Ancora Heart says enrollment has started for AccuCinch pivotal trial

Ancora Heart this week said it has enrolled the first patient in its AccuCinch Ventricular Restoration System pivotal trial.

AccuCinch is a flexible implant that is attached to the inner wall of the left ventricle and then cinched. It is designed to reduce the size of the left ventricle, reduce ventricular wall stress and support and strengthen the heart wall.

The Corcinch-HF pivotal trial will evaluate the safety and efficacy of the system in patients who have symptomatic heart failure with reduced ejection fraction. The study is being conducted to support the company’s premarket approval application for the FDA.

AccuCinch is touted as being one of the only completely transcatheter procedures to treat the enlarged left ventricle. It differs from device-based therapies that are designed to improve the structure and function of the heart to bring relief to heart failure patients who are still symptomatic.

“In patients with heart failure, the …

Read more
  • 0

Alleviant Medical wins FDA breakthrough device designation for transcath heart failure treatment

Alleviant Medical (Austin, Texas) has received FDA breakthrough device designation for its no-implant, interatrial shunt technology for treating certain types of chronic heart failure.

Founded in 2017, Alleviant’s minimally invasive transcatheter tech decompresses the left atrium without a permanent cardiac implant or open-heart surgery. Alleviant developed the teach to treat people who have heart failure with preserved (HFpEF) and mid-range ejection fraction (HFmrEF) — and remain symptomatic despite optimal guideline-directed medical therapy.

HFpEF patients have limited treatment options, according to Alleviant Medical CEO Adam L. Berman.

“By utilizing a no-implant interatrial shunt approach, the Alleviant Medical technology offers the option for a simple, minimally-invasive procedure for heart failure patients,” Berman said in a news release.

The breakthrough device designation will enable expedited development, assessment and review…

Read more
  • 0

5 innovations to make duodenoscopes more single-use — and save lives

[Images from Boston Scientific, Ambu and Olmypus]Duodenoscopes are important medical devices that are used for endoscopic retrograde cholangiopancreatography (ERCP) procedures. However, the devices have had serious problems in the past.

Luckily, several medical device companies have stepped in to solve the problems. (Here are five of the innovations.) 

Duodenoscopes are flexible, lighted tubes threaded through the mouth, throat and stomach into the top of the small intestine. They’re an important tool for spotting problems such as lesions and tumors in the pancreatic duct and bile duct, but the devices are also complex, with many small working parts.

“Duodenoscopes – regardless of whether they are reusable or single-use – are one of the most technically complex flexible endoscopes to design and manufacture, as they travel deep into the body with a camera mounted on the side instead of the front,” David Pierce, EVP and president of MedSu…

Read more
  • 0

XL Precision Technologies plans UK, U.S. expansions

XL Precision Technologies (XL-PT) has announced a major capital investment to expand facilities in the first quarter of 2021.

At the primary manufacturing site in Stockton-on-Tees (UK), XL-PT has signed the lease to the adjacent building, which will add 17,400 ft2 of floor space to the existing capacity. Occupancy is expected within three months. XL-PT expects the expansion will enable a boost in its process flow using a mix of specialized, high-technology manufacturing cells, the company said in a news release.

Get the full story on our sister site, Medical Design & Outsourcing.

Read more
  • 0

Reflow Medical launches low-profile reinforced support catheters

Reflow Medical today announced it has launched its Reflow Spex Low Profile reinforced support catheters.

The Spex LP catheters are designed to provide the lowest profile tip to access and cross the tightest and most complex lesions with a supportive system. They come in 0.014 in. and 0.018 in. sizes and can be combined with the Reflow Spex 35.

Reflow’s new catheters also have a customizable tip that can be shaped to the desired angle and is compatible with a physician’s choice of guidewires and procedural technique.

“Using the new Spex LP with the Spex 35 creates a ‘telescoping’ action for extra support,” Jay Mathres, a Bradenton Cardiology Center doctor in Bradenton, Fla., said in a news release.

“Our physician partners expressed a need for a lower-profile support catheter that doesn’t sacrifice strength. Reflow delivered,” company cofounder and COO John Fulkerson said. “This product line was advance-engineered for treating complex cr…

Read more
  • 0

Nordson acquires Fluortek

Nordson Corporation recently announced that it acquired Fluortek for an undisclosed amount.

Fluortek is a precision plastic extrusion manufacturer that works with the medical device industry to create custom dimensioned tubing.

“As Nordson Medical continues to expand its differentiated product offerings, the acquisition of Fluortek enhances our ability to deliver critical components that enable our customers’ most complex medical device innovations. This offering further supports Nordson Medical’s position as a leading full-service solution provider of component and device manufacturing capabilities for OEM’s across the interventional, minimally invasive and surgical medical device landscape,” executive VP of Nordson advanced technology solutions Jeffrey Pembroke said in a news release.

Fluortek will become a part of the Nordson Medical product line pithing the company’s advanced technology solutions segment to build upon its curr…

Read more
  • 0

Study: Medtronic’s drug-coated balloon reduces dialysis interruptions

Medtronic’s In.Pact arteriovenous drug-coated balloon (Image courtesy of the FDA)

Medtronic (NYSE:MDT) recently announced the results of a study showing that some kidney disease patients who had a drug-coated balloon (DCB) implanted to treat arteriovenous (AV) failure experienced fewer interruptions of dialysis treatment.

Many end-stage renal disease (ESRD) patients require AV fistulae in order to receive continuous dialysis. Blood vessels that feed the access site can narrow over time and patients often undergo multiple maintenance procedures per year to restore access site function. The need for frequent reinterventions can result in repeated hospital visits and significant disruptions to hemodialysis care. By being able to maintain access site patency, patients may experience longer periods of uninterrupted dialysis, according to a news release from Medtronic.

The IN.PACT AV Access trial followed 330 patients at 29 sites in U.S., Japan, and New Zealand…

Read more
  • 0

Stryker launches cobalt chromium flow diverter

Stryker this week said it launched its Surpass Evolve flow diverter after it received FDA approval.

The flow diverter is a 64-wire cobalt-chromium device designed to re-direct blood flow and promote aneurysm healing. It follows the company’s launch of Surpass Streamline in 2018.

“This device builds on the success of Surpass Streamline, offering a highly optimized and easy to use flow diverter. By increasing the braid angle, the novel 64-wire device delivers excellent flow diversion and a highly flexible implant for enhanced vessel wall contact. The higher mesh density of Surpass Evolve versus traditional 48-wire flow diverters may lead to faster aneurysm occlusion for patients,” Dr. Ajay Wakhloo, the first physician to complete a commercial case in the U.S. with the device, said in a news release.

Stryker launched the Surpass Evolve in Europe last year and said it  has since been approved in over 45 countries. More than 1,500 patients h…

Read more
  • 0