Micro Interventional Devices Submits CE Mark Technical Documentation for the MIA-T Percutaneous Tricuspid Annuloplasty System

January 28, 2021

Micro Interventional Devices has submitted the required technical documentation for CE Mark approval for its MIA-T Percutaneous Tricuspid Annuloplasty System for tricuspid valve repair to its Notified Body.

The receipt of a CE Mark would allow MID to commercialize MIA-T in the European Union in countries governed by the European Medical Device Regulations (MDR). MID is anticipating an approval in 2021. This will enable a treatment option for millions of patients currently at too high a risk to be treated with the standard of care, open surgical repair with cardiopulmonary bypass.

The MIA-T System was clinically evaluated in STTAR, the Study of Transcatheter Tricuspid Annular Repair, conducted at six European hospitals. The image-guided procedure relies on fluoroscopy and 3D echocardiography to treat patients suffering from tricuspid regurgitation while the heart is beating, obviating the need for cardiopulmonary bypass.  This less invasive treatment option would dramatically increase the number of patients who are able to receive treatment for this disease.

“CE Mark submission is a major milestone for MID,” said Michael Whitman, President and CEO of Micro Interventional Devices.  “The receipt of a CE Mark approval will allow MID to offer a safe and effective therapeutic option for patients who are poorly served by current medical and surgical options and sets the stage for the next significant phase in this company’s growth.  It is also worthy to note that this filling is being submitted under the current EU Medical Device Regulation (MDR) 2017/745.”

Thirty-one patients have been treated with the MIA-T technology to date. The initial data indicate that significant reductions in annular dimensions and tricuspid regurgitation achieved acutely with MIA-T are durable at one year follow-up.  The data also indicate significant improvements in Quality of Life for patients treated with the MIA-T system. There were no device or procedure-related deaths, strokes or myocardial infarctions reported for any patient throughout the 12-month follow-up period.  The device has not been approved for commercial use at this time.

“The clinical data from STTAR demonstrate the safety and performance of the MIA-T system,” said Willard Hennemann, PhD, MID’s Chief Science Officer.  “The encouraging clinical results, short procedure times and short learning curve demonstrated during the study suggest that the MIA-T system has the potential to readily become adopted as standard of care therapy for the treatment of moderate-severe tricuspid regurgitation upon CE Mark approval.”

Additionally, MID continues to work closely with the FDA on its IDE submission for the STTAR – US clinical trial.  This will be a multi-center trial conducted at 30 sites in the United States.  MID hopes to gain approval from the Agency to begin its US Trial for PMA approval later this year.

Medical Device News Magazinehttps://infomeddnews.com
Our publication is dedicated to bringing our readers the latest medical device news. We are proud to boast that our subscribers include medical specialists, device industry executives, investors, and other allied health professionals, as well as patients who are interested in researching various medical devices. We hope you find value in our easy-to-read publication and its overall purpose and objectives! Medical Device News Magazine is a division of PTM Healthcare Marketing, Inc. Pauline T. Mayer is the managing editor.

More News!

Data from clinical studies of STK-001 demonstrated clinical benefit for patients ages 2 to 18 years old, including reductions in seizures and improvements in cognition and behavior that support the potential for disease modificatio. Analysis of 72 patients treated in STK-001 clinical trials suggests that higher STK-001 drug exposure in brain leads to greater seizure reductions. Two-year data from the longest prospective natural history study of Dravet syndrome showed that, on average, patients experienced no meaningful improvement in convulsive seizure frequency and exhibited widening gaps in cognition and behavior despite treatment with the best available anti-seizure medicines.
"Exact Sciences is looking forward to presenting new evidence at SABCS that adds important perspectives to treating breast cancer patients and showing that some patients may be able to de-escalate treatments and still have positive outcomes," said Dr. Rick Baehner, Chief Medical Officer, Precision Oncology, Exact Sciences. "Every year, we build upon the precedent set by the Oncotype DX Breast Recurrence Score® test and its prognostic and predictive abilities to determine the chemotherapy benefit for specific breast cancer patients. We are pleased to see authorities expanding access to this test as we continue to develop key evidence in collaboration with some of the world's most prestigious, breast cancer-focused organizations."
Clozapine has been established as the most effective antipsychotic medication for treatment-resistant schizophrenia. However, it is significantly underutilized mainly due to the risk of developing agranulocytosis and the need to frequently monitor the absolute neutrophil count (ANC).
Dagi-Ben Noon, CEO of Inspira Technologies, reflects on the partnership's significance: "By Integrating our technology to oxygenate blood directly with Ennocure's infection prevention solutions, we are focusing on potentially improving patient outcomes in ICUs and paving the way for safer, more effective life-support treatments. This collaboration is expected to accelerate the development and broaden the implementation of our advanced technology."
The findings suggest that the novel, non-invasive genomic test can help physicians guide next steps for these patients, enabling them to potentially avoid unnecessary invasive procedures or accelerate time to appropriate treatment.

By using this website you agree to accept Medical Device News Magazine Privacy Policy